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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03006276 | Efficacy, Tolerability, and Safety Study of DFN-15 | PHASE3 | COMPLETED | 622 | — | — | Dec 1, 2016 | May 1, 2019 | Jan 10, 2023 | 45 | United States |
| NCT03009019 | Efficacy, Tolerability, and Safety of DFN-15 | PHASE3 | COMPLETED | 631 | — | — | Dec 1, 2016 | May 1, 2019 | Jan 10, 2023 | 43 | United States |
Percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo in the DB1 period (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]) during DB1.
Percentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1.
The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]
Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period)
| Arm | Type | Description |
|---|---|---|
| DFN-15 Active | EXPERIMENTAL | DFN-15 Active |
| DFN-15 Placebo | PLACEBO_COMPARATOR | DFN-15 Placebo |
| Name | Type | Description |
|---|---|---|
| DFN-15 Active | DRUG | - |
| DFN-15 Placebo | OTHER | - |
Inclusion Criteria: 1. A history of episodic migraine, who experience 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 attacks. 2. Patients who have migraine with or without aura...