Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01462812 | Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine | PHASE3 | COMPLETED | 223 | — | — | Jan 1, 2011 | Jun 1, 2012 | May 6, 2015 | 15 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Sumatriptan | ACTIVE_COMPARATOR | - |
| Matching placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Sumatriptan | DRUG | Sumatriptan 20mg |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: * Men or women, between the ages of 18 to 65 years * Diagnosis of migraine, with or without aura * Experiences between 1 and 8 migraine attacks per month for the past 12 months Exclusion Criteria: * Inability to distinguish other headaches from migraine * Experiences headache ...