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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02856802 | An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg) | PHASE2 | COMPLETED | 107 | — | — | Jul 11, 2016 | Feb 10, 2017 | Mar 30, 2021 | 9 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| DFN-02 | EXPERIMENTAL | Participants self-administered a single-dose of DFN-02 (sumatriptan 10-mg/100 μL nasal spray) intranasally within one hour of an acute migraine pain episode. |
| Placebo | OTHER | Participants self-administered a single-dose of DFN-02 placebo nasal spray matching DFN-02 intranasally within one hour of an acute migraine pain episode. |
| Name | Type | Description |
|---|---|---|
| Sumatriptan 10 mg Nasal Spray | DRUG | 100 μL nasal spray once |
| Sumatriptan Placebo Nasal Spray | OTHER | 100 μL nasal spray once |
Inclusion Criteria: 1. A history of episodic migraine who experience an average of 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache free time between migraine headaches 2. Patients who have migraine with o...