Trial Outcomes & Findings for Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura (NCT NCT01667679)
NCT ID: NCT01667679
Last Updated: 2017-04-12
Results Overview
SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
275 participants
Primary outcome timeframe
Baseline and 30 minutes post-dose (up to 24 weeks)
Results posted on
2017-04-12
Participant Flow
A total of 334 participants were assessed for eligibility; of these, 275 participants were randomized.
Participant milestones
| Measure |
20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)
In Treatment Period (TP) 1 (\<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1 (<=12 Weeks)
STARTED
|
138
|
137
|
|
Treatment Period 1 (<=12 Weeks)
COMPLETED
|
122
|
107
|
|
Treatment Period 1 (<=12 Weeks)
NOT COMPLETED
|
16
|
30
|
|
Treatment Period 2 (<=12 Weeks)
STARTED
|
122
|
107
|
|
Treatment Period 2 (<=12 Weeks)
COMPLETED
|
100
|
85
|
|
Treatment Period 2 (<=12 Weeks)
NOT COMPLETED
|
22
|
22
|
Reasons for withdrawal
| Measure |
20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)
In Treatment Period (TP) 1 (\<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1 (<=12 Weeks)
Failure to Treat Migraine Headache
|
2
|
6
|
|
Treatment Period 1 (<=12 Weeks)
Dosed Incorrectly
|
2
|
0
|
|
Treatment Period 1 (<=12 Weeks)
Lack of Efficacy
|
2
|
0
|
|
Treatment Period 1 (<=12 Weeks)
Could Not Tolerate Diary
|
1
|
0
|
|
Treatment Period 1 (<=12 Weeks)
Withdrawal by Subject
|
6
|
13
|
|
Treatment Period 1 (<=12 Weeks)
Adverse Event
|
3
|
3
|
|
Treatment Period 1 (<=12 Weeks)
Lost to Follow-up
|
0
|
2
|
|
Treatment Period 1 (<=12 Weeks)
Protocol Violation
|
0
|
2
|
|
Treatment Period 1 (<=12 Weeks)
Non-compliance
|
0
|
3
|
|
Treatment Period 1 (<=12 Weeks)
Moved Out of State
|
0
|
1
|
|
Treatment Period 2 (<=12 Weeks)
Withdrawal by Subject
|
6
|
4
|
|
Treatment Period 2 (<=12 Weeks)
Non-compliance with Electronic Diary
|
2
|
0
|
|
Treatment Period 2 (<=12 Weeks)
Lost to Follow-up
|
8
|
10
|
|
Treatment Period 2 (<=12 Weeks)
Non-compliance
|
3
|
4
|
|
Treatment Period 2 (<=12 Weeks)
Sponsor Decision
|
1
|
0
|
|
Treatment Period 2 (<=12 Weeks)
Failure to Treat Migraine Headache
|
1
|
0
|
|
Treatment Period 2 (<=12 Weeks)
Adverse Event
|
1
|
0
|
|
Treatment Period 2 (<=12 Weeks)
Significant Improvement in Migraine
|
0
|
1
|
|
Treatment Period 2 (<=12 Weeks)
Partially Dosed
|
0
|
1
|
|
Treatment Period 2 (<=12 Weeks)
Brought in before 12 Weeks/5 Migraines
|
0
|
1
|
|
Treatment Period 2 (<=12 Weeks)
Refused Last Day of Visit 4 Procedures
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura
Baseline characteristics by cohort
| Measure |
20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)
n=133 Participants
In Treatment Period 1 (\<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1, participants entered Treatment Period 2 (\<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril.
|
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=129 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1, participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally.
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.5 Years
STANDARD_DEVIATION 12.55 • n=99 Participants
|
40.7 Years
STANDARD_DEVIATION 11.93 • n=107 Participants
|
40.1 Years
STANDARD_DEVIATION 12.24 • n=206 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
222 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 30 minutes post-dose (up to 24 weeks)Population: Full Analysis Set (FAS): all participants who experienced at least 1 headache attack per treatment period, received at least 1 dose of study medication (sumatriptan nasal powder or tablet) in each treatment period, and had at least 1 post-Baseline assessment for a treated attack in each treatment period.
SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=185 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=185 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Mean Sum of Migraine Pain Intensity Differences (SPID)-30
|
7.41 scores on a scale
Standard Error 0.880
|
10.80 scores on a scale
Standard Error 0.880
|
SECONDARY outcome
Timeframe: Baseline and 30 minutes post-dose (up to 24 weeks)Population: FAS. Only those participants with the type of attack specified were analyzed (specified by n=X, X in the corresponding category title). A single participant could have had both a mild and a moderate/severe attack.
SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=185 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=185 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe
mild attacks, n=113, 109
|
0.24 scores on a scale
Standard Error 0.931
|
3.90 scores on a scale
Standard Error 0.921
|
|
Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe
moderate/severe attacks, n=158, 168
|
10.07 scores on a scale
Standard Error 0.997
|
13.83 scores on a scale
Standard Error 1.022
|
SECONDARY outcome
Timeframe: 10, 15, 30, 45, 60, 90, and 120 minutesPopulation: FAS. The LOCF imputation method was used in this analysis.
Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=766 number of attacks
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=765 number of attacks
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Percentage of Attacks in Which Pain Reduction Was Achieved
10 minutes post-dose
|
10.2 percentage of attacks
|
11.5 percentage of attacks
|
|
Percentage of Attacks in Which Pain Reduction Was Achieved
15 minutes post-dose
|
19.6 percentage of attacks
|
26.4 percentage of attacks
|
|
Percentage of Attacks in Which Pain Reduction Was Achieved
30 minutes post-dose
|
35.2 percentage of attacks
|
49.0 percentage of attacks
|
|
Percentage of Attacks in Which Pain Reduction Was Achieved
45 minutes post-dose
|
49.9 percentage of attacks
|
60.7 percentage of attacks
|
|
Percentage of Attacks in Which Pain Reduction Was Achieved
60 minutes post-dose
|
59.8 percentage of attacks
|
67.2 percentage of attacks
|
|
Percentage of Attacks in Which Pain Reduction Was Achieved
90 minutes post-dose
|
69.8 percentage of attacks
|
74.6 percentage of attacks
|
|
Percentage of Attacks in Which Pain Reduction Was Achieved
120 minutes post-dose
|
75.2 percentage of attacks
|
78.0 percentage of attacks
|
SECONDARY outcome
Timeframe: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)Population: FAS. The LOCF imputation method was used for this analysis.
Percentage of attacks in which pain freedom (defined as pain level reduced to none \[Grade 0\]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=766 number of attacks
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=765 number of attacks
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Percentage of Attacks in Which Pain Freedom Was Achieved
10 minutes post-dose
|
1.3 percentage of attacks
|
2.5 percentage of attacks
|
|
Percentage of Attacks in Which Pain Freedom Was Achieved
15 minutes post-dose
|
3.7 percentage of attacks
|
7.2 percentage of attacks
|
|
Percentage of Attacks in Which Pain Freedom Was Achieved
30 minutes post-dose
|
10.8 percentage of attacks
|
18.2 percentage of attacks
|
|
Percentage of Attacks in Which Pain Freedom Was Achieved
45 minutes post-dose
|
21.3 percentage of attacks
|
31.0 percentage of attacks
|
|
Percentage of Attacks in Which Pain Freedom Was Achieved
60 minutes post-dose
|
32.9 percentage of attacks
|
41.2 percentage of attacks
|
|
Percentage of Attacks in Which Pain Freedom Was Achieved
90 minutes post-dose
|
44.9 percentage of attacks
|
52.8 percentage of attacks
|
|
Percentage of Attacks in Which Pain Freedom Was Achieved
120 minutes post-dose
|
56.3 percentage of attacks
|
60.4 percentage of attacks
|
SECONDARY outcome
Timeframe: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)Population: FAS. The LOCF imputation method was used in this analysis.
Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none \[Grade 0\] or mild \[Grade 1\]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=532 number of moderate or severe attacks
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=509 number of moderate or severe attacks
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Percentage of Attacks in Which Pain Relief Was Achieved
10 minutes post-dose
|
11.5 percentage of attacks
|
13.8 percentage of attacks
|
|
Percentage of Attacks in Which Pain Relief Was Achieved
15 minutes post-dose
|
20.9 percentage of attacks
|
27.9 percentage of attacks
|
|
Percentage of Attacks in Which Pain Relief Was Achieved
30 minutes post-dose
|
38.7 percentage of attacks
|
53.8 percentage of attacks
|
|
Percentage of Attacks in Which Pain Relief Was Achieved
45 minutes post-dose
|
53.9 percentage of attacks
|
65.0 percentage of attacks
|
|
Percentage of Attacks in Which Pain Relief Was Achieved
60 minutes post-dose
|
62.6 percentage of attacks
|
72.1 percentage of attacks
|
|
Percentage of Attacks in Which Pain Relief Was Achieved
90 minutes post-dose
|
72.0 percentage of attacks
|
77.4 percentage of attacks
|
|
Percentage of Attacks in Which Pain Relief Was Achieved
120 minutes post-dose
|
76.9 percentage of attacks
|
79.6 percentage of attacks
|
SECONDARY outcome
Timeframe: 120 minutes post-dose (up to 24 weeks)Population: FAS. If the participant did not report pain freedom within 120 minutes post-dose, he/she was considered to be censored at the last non-missing result prior to the 120-minute time point.
Pain freedom is defined as a pain level reduced to none (Grade 0).
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=185 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=185 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Median Time to Pain Freedom
|
121 minutes
Interval 91.0 to 121.0
|
91 minutes
The confidence interval is un-estimable due to the number of participants who were observed pain free at the post-dose time points.
|
SECONDARY outcome
Timeframe: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)Population: FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.
Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=185 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=185 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
10 minutes post-dose
|
-0.09 scores on a scale
Standard Error 0.018
|
-0.11 scores on a scale
Standard Error 0.018
|
|
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
15 minutes post-dose
|
-0.18 scores on a scale
Standard Error 0.029
|
-0.26 scores on a scale
Standard Error 0.029
|
|
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
30 minutes post-dose
|
-0.38 scores on a scale
Standard Error 0.042
|
-0.56 scores on a scale
Standard Error 0.042
|
|
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
45 minutes post-dose
|
-0.60 scores on a scale
Standard Error 0.049
|
-0.77 scores on a scale
Standard Error 0.049
|
|
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
60 minutes post-dose
|
-0.79 scores on a scale
Standard Error 0.051
|
-0.93 scores on a scale
Standard Error 0.051
|
|
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
90 minutes post-dose
|
-0.98 scores on a scale
Standard Error 0.052
|
-1.09 scores on a scale
Standard Error 0.052
|
|
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
120 minutes post-dose
|
-1.15 scores on a scale
Standard Error 0.053
|
-1.19 scores on a scale
Standard Error 0.053
|
SECONDARY outcome
Timeframe: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)Population: FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.
Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=185 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=185 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
10 minutes post-dose
|
-0.03 scores on a scale
Standard Error 0.017
|
-0.08 scores on a scale
Standard Error 0.017
|
|
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
15 minutes post-dose
|
-0.09 scores on a scale
Standard Error 0.025
|
-0.18 scores on a scale
Standard Error 0.025
|
|
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
30 minutes post-dose
|
-0.26 scores on a scale
Standard Error 0.038
|
-0.42 scores on a scale
Standard Error 0.038
|
|
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
45 minutes post-dose
|
-0.43 scores on a scale
Standard Error 0.046
|
-0.60 scores on a scale
Standard Error 0.046
|
|
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
60 minutes post-dose
|
-0.56 scores on a scale
Standard Error 0.049
|
-0.73 scores on a scale
Standard Error 0.049
|
|
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
90 minutes post-dose
|
-0.72 scores on a scale
Standard Error 0.052
|
-0.83 scores on a scale
Standard Error 0.052
|
|
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
120 minutes post-dose
|
-0.85 scores on a scale
Standard Error 0.054
|
-0.92 scores on a scale
Standard Error 0.054
|
SECONDARY outcome
Timeframe: Baseline compared to Vist 2, 3 and 4Population: Safety Analysis Set: all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet
An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=228 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=219 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event
Treatment-emergent Adverse Event
|
73 participants
|
118 participants
|
|
Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event
Treatment-emergent Serious Adverse Event
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=124 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
Visit 3
|
-1.3 grams per Liter (g/L)
Standard Deviation 6.66
|
-1.3 grams per Liter (g/L)
Standard Deviation 6.07
|
|
Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
Visit 4
|
-0.8 grams per Liter (g/L)
Standard Deviation 6.63
|
-2.7 grams per Liter (g/L)
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in hematocrit (proportion of total blood volume that is composed of red blood cells) was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=124 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
Visit 3, n=108, 94
|
-0.005 proportion
Standard Deviation 0.0222
|
-0.002 proportion
Standard Deviation 0.0204
|
|
Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
Visit 4, n=124, 110
|
-0.002 proportion
Standard Deviation 0.0198
|
-0.005 proportion
Standard Deviation 0.0222
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in red blood cell count was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=124 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 3, n=109, 95
|
-0.04 10^12 cells per Liter
Standard Deviation 0.280
|
-0.02 10^12 cells per Liter
Standard Deviation 0.227
|
|
Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 4, n=124, 110
|
-0.02 10^12 cells per Liter
Standard Deviation 0.209
|
-0.05 10^12 cells per Liter
Standard Deviation 0.228
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in white blood cell (WBC) count, basinophils, monocytes, neutrophils, lymphocytes, eosinophils, and platelets was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=124 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
WBC Count, Visit 3, n=109, 95
|
-0.19 10^9 cells per Liter
Standard Deviation 1.381
|
-0.10 10^9 cells per Liter
Standard Deviation 1.398
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
WBC Count, Visit 4, n=124, 110
|
-0.09 10^9 cells per Liter
Standard Deviation 1.464
|
-0.05 10^9 cells per Liter
Standard Deviation 1.477
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Basophils, Visit 3, n=108, 95
|
0.000 10^9 cells per Liter
Standard Deviation 0.0297
|
0.000 10^9 cells per Liter
Standard Deviation 0.0301
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Basophils, Visit 4, n=124, 110
|
-0.001 10^9 cells per Liter
Standard Deviation 0.0235
|
0.000 10^9 cells per Liter
Standard Deviation 0.0283
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Monocytes, Visit 3, n=108, 95
|
-0.022 10^9 cells per Liter
Standard Deviation 0.1160
|
-0.030 10^9 cells per Liter
Standard Deviation 0.1356
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Monocytes, Visit 4, n=124, 110
|
-0.026 10^9 cells per Liter
Standard Deviation 0.1281
|
-0.014 10^9 cells per Liter
Standard Deviation 0.1504
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Neutrophils, Visit 3, n=108, 95
|
-0.134 10^9 cells per Liter
Standard Deviation 1.1600
|
-0.052 10^9 cells per Liter
Standard Deviation 1.2553
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Neutrophils, Visit 4, n=124, 110
|
-0.057 10^9 cells per Liter
Standard Deviation 1.2885
|
-0.059 10^9 cells per Liter
Standard Deviation 1.4270
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Lymphocytes, Visit 3, n=108, 95
|
-0.038 10^9 cells per Liter
Standard Deviation 0.3892
|
-0.049 10^9 cells per Liter
Standard Deviation 0.4702
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Lymphocytes, Visit 4, n=124, 110
|
-0.020 10^9 cells per Liter
Standard Deviation 0.3925
|
0.012 10^9 cells per Liter
Standard Deviation 0.4252
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Eosinophils, Visit 3, n=108, 95
|
0.006 10^9 cells per Liter
Standard Deviation 0.0493
|
-0.001 10^9 cells per Liter
Standard Deviation 0.0766
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Eosinophils, Visit 4, n=124, 110
|
0.013 10^9 cells per Liter
Standard Deviation 0.0824
|
0.012 10^9 cells per Liter
Standard Deviation 0.1068
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Platelets, Visit 3, n=109, 93
|
-8.2 10^9 cells per Liter
Standard Deviation 46.92
|
-1.9 10^9 cells per Liter
Standard Deviation 29.14
|
|
Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Platelets, Visit 4, n=123, 110
|
-7.5 10^9 cells per Liter
Standard Deviation 43.40
|
-4.0 10^9 cells per Liter
Standard Deviation 27.92
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in urea was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=123 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 3, n=108, 94
|
0.079 millimoles per Liter (mmol/L)
Standard Deviation 1.2227
|
0.070 millimoles per Liter (mmol/L)
Standard Deviation 1.2118
|
|
Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 4, n=123, 110
|
0.308 millimoles per Liter (mmol/L)
Standard Deviation 1.3674
|
0.156 millimoles per Liter (mmol/L)
Standard Deviation 1.2840
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in creatinine was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=123 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 3, n=108, 94
|
-0.7 micromoles per Liter (µmol/L)
Standard Deviation 6.59
|
-1.9 micromoles per Liter (µmol/L)
Standard Deviation 10.73
|
|
Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 4, n=123, 110
|
-0.6 micromoles per Liter (µmol/L)
Standard Deviation 8.24
|
-1.3 micromoles per Liter (µmol/L)
Standard Deviation 11.77
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in ALP and ALT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=123 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
ALP, Visit 3, n=108, 94
|
0.0 International Units per Liter (IU/L)
Standard Deviation 6.78
|
-0.5 International Units per Liter (IU/L)
Standard Deviation 8.92
|
|
Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
ALP, Visit 4, n=123, 110
|
-1.0 International Units per Liter (IU/L)
Standard Deviation 9.45
|
-1.7 International Units per Liter (IU/L)
Standard Deviation 9.92
|
|
Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
ALT, Visit 3, n=108, 94
|
0.0 International Units per Liter (IU/L)
Standard Deviation 8.86
|
0.4 International Units per Liter (IU/L)
Standard Deviation 7.08
|
|
Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
ALT, Visit 4, n=123, 110
|
-0.9 International Units per Liter (IU/L)
Standard Deviation 7.16
|
0.4 International Units per Liter (IU/L)
Standard Deviation 6.83
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in AST and GGT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=123 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
AST, Visit 3, n=108, 92
|
0.5 International Units per Liter (IU/L)
Standard Deviation 14.39
|
-0.2 International Units per Liter (IU/L)
Standard Deviation 5.26
|
|
Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
AST, Visit 4, n=123, 110
|
-1.2 International Units per Liter (IU/L)
Standard Deviation 5.84
|
0.6 International Units per Liter (IU/L)
Standard Deviation 7.88
|
|
Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
GGT, Visit 3, n=108, 94
|
0.0 International Units per Liter (IU/L)
Standard Deviation 7.05
|
0.8 International Units per Liter (IU/L)
Standard Deviation 10.09
|
|
Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
GGT, Visit 4, n=123, 110
|
-0.7 International Units per Liter (IU/L)
Standard Deviation 7.35
|
0.4 International Units per Liter (IU/L)
Standard Deviation 10.31
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in total bilirubin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=123 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 3, n=108, 94
|
-0.2 Units per Liter (U/L)
Standard Deviation 2.96
|
0.2 Units per Liter (U/L)
Standard Deviation 4.26
|
|
Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 4, n=123, 110
|
0.2 Units per Liter (U/L)
Standard Deviation 4.01
|
-0.6 Units per Liter (U/L)
Standard Deviation 4.09
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in albumin and total protein was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=123 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
albumin, Visit 3, n=108, 94
|
-0.9 grams per Liter (grams/L)
Standard Deviation 2.84
|
-0.8 grams per Liter (grams/L)
Standard Deviation 2.82
|
|
Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
albumin, Visit 4, n=123, 110
|
-0.5 grams per Liter (grams/L)
Standard Deviation 2.62
|
-0.9 grams per Liter (grams/L)
Standard Deviation 2.98
|
|
Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
total protein, Visit 3, n=108, 94
|
-1.2 grams per Liter (grams/L)
Standard Deviation 3.61
|
-1.0 grams per Liter (grams/L)
Standard Deviation 3.75
|
|
Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
total protein, Visit 4, n=122, 110
|
-1.0 grams per Liter (grams/L)
Standard Deviation 3.35
|
-1.2 grams per Liter (grams/L)
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in sodium, potassium, chloride, calcium, and glucose was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=110 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=123 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
sodium, Visit 3, n=108, 94
|
-0.5 mmoles/L
Standard Deviation 2.24
|
-0.3 mmoles/L
Standard Deviation 2.62
|
|
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
sodium, Visit 4, n=122, 110
|
-0.2 mmoles/L
Standard Deviation 2.25
|
-0.3 mmoles/L
Standard Deviation 2.76
|
|
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
potassium, Visit 3, n=108, 94
|
-0.04 mmoles/L
Standard Deviation 0.404
|
-0.08 mmoles/L
Standard Deviation 0.440
|
|
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
potassium, Visit 4, n=122, 110
|
-0.00 mmoles/L
Standard Deviation 0.406
|
-0.10 mmoles/L
Standard Deviation 0.411
|
|
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
chloride, Visit 3, n=108, 94
|
0.0 mmoles/L
Standard Deviation 2.39
|
-0.1 mmoles/L
Standard Deviation 2.95
|
|
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
chloride, Visit 4, n=122, 110
|
0.2 mmoles/L
Standard Deviation 2.51
|
0.2 mmoles/L
Standard Deviation 2.62
|
|
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
calcium, Visit 3, n=108, 94
|
-0.016 mmoles/L
Standard Deviation 0.1043
|
-0.019 mmoles/L
Standard Deviation 0.1017
|
|
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
calcium, Visit 4, n=123, 110
|
-0.006 mmoles/L
Standard Deviation 0.0886
|
-0.011 mmoles/L
Standard Deviation 0.1058
|
|
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
glucose, Visit 3, n=108, 94
|
0.05 mmoles/L
Standard Deviation 0.930
|
0.34 mmoles/L
Standard Deviation 1.316
|
|
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
glucose, Visit 4, n=123, 110
|
0.24 mmoles/L
Standard Deviation 1.135
|
0.20 mmoles/L
Standard Deviation 1.063
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in urinalysis values was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=109 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=124 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 3, n=108, 95
|
-0.03 pH
Standard Deviation 0.720
|
-0.04 pH
Standard Deviation 0.603
|
|
Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 4, n=124, 109
|
-0.07 pH
Standard Deviation 0.658
|
0.01 pH
Standard Deviation 0.664
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set
The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Data are based on standard reads, with "1+," "2+," and "3+" indicating increasing amounts of metabolites in urine.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=129 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=133 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Baseline, negative
|
105 participants
|
112 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Baseline, trace
|
19 participants
|
16 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Baseline, 1+
|
3 participants
|
5 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Baseline, 2+
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Visit 3, negative
|
75 participants
|
92 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Visit 3, trace
|
15 participants
|
11 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Visit 3, 1+
|
5 participants
|
4 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Visit 3, 2+
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Visit 4, negative
|
90 participants
|
104 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Visit 4, trace
|
12 participants
|
17 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Visit 4, 1+
|
6 participants
|
3 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Protein, Visit 4, 2+
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Glucose, Baseline, negative
|
126 participants
|
132 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Glucose, Baseline, trace
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Glucose, Baseline, 3+
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Glucose, Visit 3, negative
|
94 participants
|
107 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Glucose, Visit 3, trace
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Glucose, Visit 3, 3+
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Glucose, Visit 4, negative
|
108 participants
|
122 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Glucose, Visit 4, trace
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Glucose, Visit 4, 1+
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Glucose, Visit 4, 3+
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Baseline, negative
|
121 participants
|
124 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Baseline, trace
|
7 participants
|
7 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Baseline, 1+
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Baseline, 2+
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Visit 3, negative
|
88 participants
|
102 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Visit 3, trace
|
6 participants
|
5 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Visit 3, 1+
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Visit 3, 2+
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Visit 4, negative
|
101 participants
|
119 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Visit 4, trace
|
8 participants
|
3 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Ketones, Visit 4, 1+
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Baseline, negative
|
116 participants
|
116 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Baseline, trace
|
4 participants
|
7 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Baseline, 1+
|
3 participants
|
2 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Baseline, 2+
|
1 participants
|
5 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Baseline, 3+
|
5 participants
|
3 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Visit 3, negative
|
78 participants
|
94 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Visit 3, trace
|
6 participants
|
4 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Visit 3, 1+
|
4 participants
|
5 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Visit 3, 2+
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Visit 3, 3+
|
5 participants
|
3 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Visit 4, negative
|
94 participants
|
111 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Visit 4, trace
|
6 participants
|
3 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Visit 4, 1+
|
5 participants
|
1 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Visit 4, 2+
|
3 participants
|
4 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Blood, Visit 4, 3+
|
1 participants
|
5 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Baseline, negative
|
101 participants
|
99 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Baseline, trace
|
8 participants
|
12 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Baseline, 1+
|
11 participants
|
12 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Baseline, 2+
|
5 participants
|
7 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Baseline, 3+
|
4 participants
|
3 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Visit 3, negative
|
75 participants
|
90 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Visit 3, trace
|
7 participants
|
8 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Visit 3, 1+
|
4 participants
|
4 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Visit 3, 2+
|
6 participants
|
5 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Visit 3, 3+
|
3 participants
|
1 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Visit 4, negative
|
85 participants
|
105 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Visit 4, trace
|
7 participants
|
5 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Visit 4, 1+
|
5 participants
|
4 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Visit 4, 2+
|
8 participants
|
8 participants
|
|
Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
WBCs, Visit 4, 3+
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in SBP and DBP was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=111 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=124 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
SBP, Visit 3, n=110, 95
|
1.5 millimeters of mercury (mmHg)
Standard Deviation 11.46
|
0.1 millimeters of mercury (mmHg)
Standard Deviation 11.58
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
SBP, Visit 4, n=124, 111
|
2.0 millimeters of mercury (mmHg)
Standard Deviation 11.94
|
1.6 millimeters of mercury (mmHg)
Standard Deviation 11.52
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
DBP, Visit 3, n=110, 95
|
1.0 millimeters of mercury (mmHg)
Standard Deviation 8.89
|
-0.2 millimeters of mercury (mmHg)
Standard Deviation 7.17
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
DBP, Visit 4, n=124, 111
|
-0.2 millimeters of mercury (mmHg)
Standard Deviation 7.90
|
0.2 millimeters of mercury (mmHg)
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Change from Baseline in pulse was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=111 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=124 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 3, n=110, 95
|
0.1 beats per minute
Standard Deviation 9.24
|
0.1 beats per minute
Standard Deviation 8.63
|
|
Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Visit 4, n=124, 111
|
-0.2 beats per minute
Standard Deviation 10.96
|
-2.2 beats per minute
Standard Deviation 9.07
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set
The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). A categorization of "normal" or "abnormal" was made per the investigators' clinical judgment of the ECG, taking the participants' demographic characteristics and other medical conditions into account. CS = clinically significant. CNS = clinically not significant.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=129 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=133 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Visit 3, abnormal, CNS; n=110, 95
|
25 participants
|
31 participants
|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Visit 4, normal; n=124, 111
|
73 participants
|
90 participants
|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Visit 4, abnormal, CS; n=124, 111
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Visit 4, abnormal, CNS; n=123, 111
|
37 participants
|
34 participants
|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Baseline, normal; n=133, 129
|
99 participants
|
96 participants
|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Baseline, abnormal, CS; n=133, 129
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Baseline, abnormal, CNS; n=133, 129
|
30 participants
|
36 participants
|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Visit 3, normal; n=110, 95
|
70 participants
|
79 participants
|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Visit 3, abnormal, CS; n=110, 95
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)Population: Safety Analysis Set
The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). CS = clinically significant. CNS = clinically not significant.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=129 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=133 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Baseline, CS; n=133, 129
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Baseline, CNS; n=133, 129
|
129 participants
|
132 participants
|
|
Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Visit 3, CS; n=110, 95
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Visit 3, CNS; n=110, 95
|
93 participants
|
109 participants
|
|
Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Visit 4, CS; n=124, 111
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Visit 4, CNS; n=124, 111
|
111 participants
|
124 participants
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: Safety Analysis Set
Concomitant medications are defined as non-study medications with a start or stop date between the first dose of study medication and the end of safety follow-up, inclusive. Derm. = dermatologic; incl. - including.
Outcome measures
| Measure |
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
n=228 Participants
In Treatment Period 1 (\<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (\<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat \<=5 qualifying migraine headaches during Treatment Period 2.
|
20 mg Sumatriptan Nasal Powder
n=219 Participants
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Number of Participants With the Indicated Concomitant Medications
Antiseptics and disinfectants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Laxatives
|
3 participants
|
4 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Muscle relaxants
|
16 participants
|
12 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Nasal preparations
|
27 participants
|
25 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Sex hormones and modulators of the genital system
|
59 participants
|
62 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Vaccines
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Vitamins
|
56 participants
|
57 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Beta blocking agents
|
15 participants
|
18 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Calcium channel blockers
|
8 participants
|
9 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Cardiac therapy
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Corticosteroids for systemic use
|
8 participants
|
7 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Corticosteroids, dermatologic preparations
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Cough and cold preparations
|
9 participants
|
8 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Diuretics
|
7 participants
|
6 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Drugs for acid related disorders
|
23 participants
|
22 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Drugs for functional gastrointestinal disorders
|
3 participants
|
5 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Drugs for obstructive airways diseases
|
26 participants
|
20 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Drugs for treatment of bone diseases
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Drugs used in diabetes
|
9 participants
|
7 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Ectoparasiticides, incl. scabacides, insecticides
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Gynecological antiinfectives and antiseptics
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Immune sera and immunoglobulins
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Lipid modifying agents
|
20 participants
|
23 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Mineral supplements
|
22 participants
|
20 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Opthalmologicals
|
6 participants
|
7 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Other alimentary tract and metabolism products
|
5 participants
|
5 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Other dermatological preparations
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Other gynecologicals
|
21 participants
|
21 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Other nervous system drugs
|
3 participants
|
3 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Otologicals
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Psychoanaleptics
|
60 participants
|
57 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Psycholeptics
|
31 participants
|
31 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Thyroid therapy
|
16 participants
|
18 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Unspecified herbal and traditional medicine
|
12 participants
|
11 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Urologicals
|
4 participants
|
3 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antithrombotic agents
|
8 participants
|
8 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antivirals for systemic use
|
3 participants
|
2 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Any concomitant medication
|
226 participants
|
218 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Agents acting on the renin-angiotensin system
|
14 participants
|
12 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Other therapeutic products
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Allergens
|
4 participants
|
3 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Anabolic agents for systemic use
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Analgesics
|
148 participants
|
143 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Anesthetics
|
6 participants
|
6 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Anti-acne preparations
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Anti-Parkinson drugs
|
3 participants
|
3 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antianemic preparations
|
20 participants
|
18 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antibacterials for systemic use
|
17 participants
|
13 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antibiotics and chemotherapeutics for derm. use
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antidiarrrheals, intestinal antiinflammatories
|
6 participants
|
7 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antiemetics and antinauseants
|
12 participants
|
11 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antigout preparations
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antimyotics for systemic use
|
3 participants
|
1 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antiobesity preparations, exluding diet products
|
3 participants
|
3 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antiprotozoals
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antiepileptics
|
4 participants
|
5 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antihistamines for systemic use
|
39 participants
|
38 participants
|
|
Number of Participants With the Indicated Concomitant Medications
Antiinflammatory and antirheumatic products
|
143 participants
|
135 participants
|
Adverse Events
20 mg Sumatriptan Nasal Powder
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
100 mg Sumatriptan Tablet
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
20 mg Sumatriptan Nasal Powder
n=219 participants at risk
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
|
100 mg Sumatriptan Tablet
n=228 participants at risk
Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.1%
9/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
3.1%
7/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
General disorders
Product taste abnormal
|
26.0%
57/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
3.9%
9/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
Infections and infestations
Ear infection
|
0.46%
1/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
1.3%
3/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
Infections and infestations
Gastroenteritis viral
|
0.46%
1/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
1.3%
3/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
Infections and infestations
Sinusitis
|
1.4%
3/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
1.8%
4/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
9/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
3.5%
8/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.46%
1/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
1.3%
3/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
Nervous system disorders
Headache
|
0.91%
2/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
1.3%
3/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
15.5%
34/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
1.3%
3/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
1.4%
3/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
0.00%
0/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.8%
4/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
0.00%
0/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.7%
6/219 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
0.88%
2/228 • Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
|
Additional Information
Nadine Knowles; Executive Director, Research & Development Operations
Avanir Pharmaceuticals
Phone: 1-949-268-8972
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER