Trial Outcomes & Findings for An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg) (NCT NCT02856802)
NCT ID: NCT02856802
Last Updated: 2021-03-30
Results Overview
Freedom from headache pain at 2 hours after the first dose of study medication taken within one hour after experiencing a migraine attack of moderate to severe headache pain during the DB1 treatment period, e.g., headache pain rating of moderate \[Grade 2\] or severe \[Grade 3\] predose and reduced to none \[Grade 0\] postdose). Mild headache pain was recorded as Grade 1. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. If the subject experienced insufficient relief from the first dose of study medication, they were permitted to take a second dose of study medication or rescue medication 2 or more hours after the first dose, and only after completing the 2 hours' postdose assessments. If no relief was experienced from the first dose of study medication after 2 hours only rescue medication could be administered. Maximum 2 doses of study medication per 24 hours.
COMPLETED
PHASE2
107 participants
2 hours after study medication administration
2021-03-30
Participant Flow
The study was conducted in the United States. At least 1 subject was enrolled at 9 study centers.
Subjects had to have an average of 2 to 8 migraine attacks per month for at least the prior 12 months, with no more than 14 headache days per month, and with 48 hours of headache free time between migraine.
Participant milestones
| Measure |
DFN-02
DFN-02 Active Nasal Sumatriptan 10mg spray upon onset of acute migraine pain during each acute migraine episode
DFN-02
|
Placebo
DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode
DFN-02 Placebo
|
|---|---|---|
|
Double-Blind Treatment Period 1
STARTED
|
50
|
43
|
|
Double-Blind Treatment Period 1
COMPLETED
|
48
|
38
|
|
Double-Blind Treatment Period 1
NOT COMPLETED
|
2
|
5
|
|
Double-Blind Treatment Period 2
STARTED
|
37
|
38
|
|
Double-Blind Treatment Period 2
COMPLETED
|
36
|
38
|
|
Double-Blind Treatment Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
DFN-02
DFN-02 Active Nasal Sumatriptan 10mg spray upon onset of acute migraine pain during each acute migraine episode
DFN-02
|
Placebo
DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode
DFN-02 Placebo
|
|---|---|---|
|
Double-Blind Treatment Period 1
Withdrawal by Subject
|
0
|
2
|
|
Double-Blind Treatment Period 1
Lost to Follow-up
|
1
|
0
|
|
Double-Blind Treatment Period 1
Protocol Violation
|
0
|
1
|
|
Double-Blind Treatment Period 1
Sponsor terminated
|
1
|
0
|
|
Double-Blind Treatment Period 1
Lack of diary compliance
|
0
|
2
|
|
Double-Blind Treatment Period 2
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)
Baseline characteristics by cohort
| Measure |
DFN-02 (Double-Blind Treatment Period 1)
n=50 Participants
50 of 54 randomized subjects started and were dosed; 2 subjects had no migraine attack, 1 subject withdrew and 1 subject was lost to follow-up. Per protocol these 4 subjects are excluded from analysis.
|
Placebo (Double-Blind Treatment Period 1)
n=43 Participants
43 of 53 randomized subjects started and were dosed; 6 subjects had no migraine attack, 3 subjects withdrew and 1 subject was terminated by the sponsor. Per protocol these 10 subjects are excluded from analysis.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.4 years
n=99 Participants
|
41.0 years
n=107 Participants
|
42.3 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
42 participants
n=99 Participants
|
40 participants
n=107 Participants
|
82 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
43 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
BMI
|
27.70 kg/m^2
STANDARD_DEVIATION 6.441 • n=99 Participants
|
28.80 kg/m^2
STANDARD_DEVIATION 7.500 • n=107 Participants
|
28.21 kg/m^2
STANDARD_DEVIATION 6.933 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 hours after study medication administrationPopulation: Full Analysis Set (FAS) population. Last observation carried forward (LOCF) imputation method. The FAS included all randomized subjects who took at least one dose of study medication during the DB treatment period (1) and had at least one post-baseline efficacy time point assessment in DB treatment period (1).
Freedom from headache pain at 2 hours after the first dose of study medication taken within one hour after experiencing a migraine attack of moderate to severe headache pain during the DB1 treatment period, e.g., headache pain rating of moderate \[Grade 2\] or severe \[Grade 3\] predose and reduced to none \[Grade 0\] postdose). Mild headache pain was recorded as Grade 1. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. If the subject experienced insufficient relief from the first dose of study medication, they were permitted to take a second dose of study medication or rescue medication 2 or more hours after the first dose, and only after completing the 2 hours' postdose assessments. If no relief was experienced from the first dose of study medication after 2 hours only rescue medication could be administered. Maximum 2 doses of study medication per 24 hours.
Outcome measures
| Measure |
DFN-02 (DB1)
n=48 Participants
DFN-02 Active Nasal Sumatriptan 10mg spray upon onset of acute migraine pain during each acute migraine episode
DFN-02
|
Placebo (DB1)
n=40 Participants
DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode
DFN-02 Placebo
|
|---|---|---|
|
Number of Participants Free From Headache Pain at 2 Hours After the First Dose of Study Medication Taken for a Migraine Attack With Moderate to Severe Headache Pain During the Double-blind Treatment Period 1 (DB1).
|
21 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 2 hours after study medication administrationPopulation: Subjects who reported a MBS predose and reported the status of the MBS at the particular postdose time point were analyzed.
Number of participants with their MBS among nausea, photophobia and phonophobia absent at 10, 15, 20, 30, 60, 90, and 120 minutes after the first dose of study medication taken for a migraine attack during DB1 treatment period are summarized by treatment group and time point for the full analysis set (FAS1). The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups. Subjects who reported a MBS predose and reported the status of the MBS at the particular postdose time point were analyzed.
Outcome measures
| Measure |
DFN-02 (DB1)
n=41 Participants
DFN-02 Active Nasal Sumatriptan 10mg spray upon onset of acute migraine pain during each acute migraine episode
DFN-02
|
Placebo (DB1)
n=38 Participants
DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode
DFN-02 Placebo
|
|---|---|---|
|
Number of Participants With Absence of Most Bothersome Symptom (MBS) Among Nausea, Photophobia and Phonophobia at 2 Hours (DB1)
|
29 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 2 hours after study medication administrationPopulation: Last observation carried forward (LOCF) imputation method. Analysis included all randomized subjects who took at least one dose of study medication during the second DB treatment period (2) and had at least one post-baseline efficacy time point assessment in DB treatment period (2).
In Double-blind Treatment Period 2 (DB2), freedom from headache pain 2 hours after the first dose of study medication taken within one hour of experiencing a migraine attack for any headache pain level, e.g., mild \[Grade 1\], moderate \[Grade 2\], or severe \[Grade 3\] and reduced to none \[Grade 0\] after study medication administration. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack.
Outcome measures
| Measure |
DFN-02 (DB1)
n=36 Participants
DFN-02 Active Nasal Sumatriptan 10mg spray upon onset of acute migraine pain during each acute migraine episode
DFN-02
|
Placebo (DB1)
n=37 Participants
DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode
DFN-02 Placebo
|
|---|---|---|
|
Number of Participants With Headache Pain Freedom at 2 Hours Postdose in the Double-blind Treatment Period 2 (DB2)
|
19 Participants
|
17 Participants
|
Adverse Events
DFN-02 (DB1)
Placebo (DB1)
DFN-02 (DB2)
Placebo (DB2)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DFN-02 (DB1)
n=50 participants at risk
DFN-02 Active Nasal Sumatriptan 10-mg spray upon onset of acute migraine pain during each acute migraine episode
DFN-02 Active in Double-blind Treatment Period 1
|
Placebo (DB1)
n=43 participants at risk
DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode
DFN-02 Placebo in Double-blind Treatment Period 1
|
DFN-02 (DB2)
n=37 participants at risk
DFN-02 Active Nasal Sumatriptan 10-mg spray upon onset of acute migraine pain during each acute migraine episode
DFN-02 Active in Double-blind Treatment Period 2
|
Placebo (DB2)
n=38 participants at risk
DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode
DFN-02 Placebo in Double-blind Treatment Period 2
|
|---|---|---|---|---|
|
General disorders
Application site pain
|
2.0%
1/50 • Number of events 1 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/43 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
2.7%
1/37 • Number of events 1 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/38 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
|
General disorders
Chest Discomfort
|
2.0%
1/50 • Number of events 1 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/43 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/37 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/38 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
2.0%
1/50 • Number of events 1 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/43 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/37 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/38 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
|
Nervous system disorders
Burning sensation
|
2.0%
1/50 • Number of events 1 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/43 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/37 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/38 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/50 • Number of events 1 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/43 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
8.1%
3/37 • Number of events 3 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/38 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/50 • Number of events 1 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/43 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/37 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/38 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
|
General disorders
Malaise
|
0.00%
0/50 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/43 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
2.7%
1/37 • Number of events 1 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/38 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/50 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/43 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
2.7%
1/37 • Number of events 1 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
0.00%
0/38 • Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place