Trial Outcomes & Findings for Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine (NCT NCT01462812)
NCT ID: NCT01462812
Last Updated: 2015-05-06
Results Overview
The primary objective for this study is to compare headache relief (defined as a reduction from moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\] or mild \[Grade 1\] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.
COMPLETED
PHASE3
223 participants
120 Minutes
2015-05-06
Participant Flow
private practices and research clinics
Screening period (general medical exams, labs, medical and headache history, concomitant medications.
Participant milestones
| Measure |
Matching Placebo
Placebo : Matching placebo
|
Sumatriptan
Sumatriptan : Sumatriptan 20mg
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
112
|
|
Overall Study
COMPLETED
|
111
|
111
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine
Baseline characteristics by cohort
| Measure |
Matching Placebo
n=111 Participants
Placebo : Matching placebo
|
Sumatriptan
n=112 Participants
Sumatriptan : Sumatriptan 20mg
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
111 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
223 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 10.71 • n=99 Participants
|
42.2 years
STANDARD_DEVIATION 10.27 • n=107 Participants
|
42.2 years
STANDARD_DEVIATION 10.47 • n=206 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=99 Participants
|
112 participants
n=107 Participants
|
223 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 120 MinutesPopulation: The full analysis dataset (FAD) will include all subjects who are randomized, receive study medication, and record at least one post-treatment assessment of pain severity. The treatment group assignment will be designated according to treatment received. The FAD will serve as the basis for the efficacy analyses.
The primary objective for this study is to compare headache relief (defined as a reduction from moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\] or mild \[Grade 1\] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.
Outcome measures
| Measure |
Matching Placebo
n=104 Participants
Placebo : Matching placebo
|
Sumatriptan
n=108 Participants
Sumatriptan : Sumatriptan 20mg
|
|---|---|---|
|
Headache Relief
|
47 participants
|
73 participants
|
Adverse Events
Matching Placebo
Sumatriptan
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Matching Placebo
n=111 participants at risk
Placebo : Matching placebo
|
Sumatriptan
n=112 participants at risk
Sumatriptan : Sumatriptan 20mg
|
|---|---|---|
|
General disorders
Product Taste Abnormal
|
3.6%
4/111 • 17 months
|
22.3%
25/112 • 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
1.8%
2/111 • 17 months
|
13.4%
15/112 • 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.7%
3/111 • 17 months
|
5.4%
6/112 • 17 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/111 • 17 months
|
2.7%
3/112 • 17 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Found in PI contract.
- Publication restrictions are in place
Restriction type: OTHER