Acute Treatment Trial in Adult Subjects With Migraines
Summary
The purpose of the study is to evaluate the safety and efficacy of three different intranasal dose levels of zavegepant (BHV-3500), relative to placebo, in the acute treatment of moderate to severe migraine.
Timeline
- Start
- 2019-03-25
- Primary completion
- 2019-10-31
- Completion
- 2019-11-11
Outcome
Mixed primary results
registry NUMBER Zavegepant 5 mg: 19.6 (14.8 to 24.5) percentage of participants NCT03872453 ↗
registry NUMBER Placebo: 15.5 (11.1 to 19.8) percentage of participants NCT03872453 ↗
registry analysis (superiority test); Zavegepant 5 mg vs Placebo; p = 0.1214; NCT03872453 ↗
registry NUMBER Zavegepant 10 mg: 22.5 (17.5 to 27.6) percentage of participants NCT03872453 ↗
registry analysis (superiority test); Zavegepant 10 mg vs Placebo; p = 0.0113; NCT03872453 ↗
registry NUMBER Zavegepant 20 mg: 23.1 (18.1 to 28.2) percentage of participants NCT03872453 ↗
registry analysis (superiority test); Zavegepant 20 mg vs Placebo; p = 0.0055; NCT03872453 ↗
registry analysis (superiority test); Zavegepant 5 mg vs Placebo; p = 0.1162; NCT03872453 ↗
registry analysis (superiority test); Zavegepant 10 mg vs Placebo; p = 0.0155; NCT03872453 ↗
registry analysis (superiority test); Zavegepant 20 mg vs Placebo; p = 0.0094; NCT03872453 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zavegepant | Small molecule | 5 mg | Intranasal |
| Subject | Zavegepant | Small molecule | 10 mg | Intranasal |
| Subject | Zavegepant | Small molecule | 20 mg | Intranasal |