A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
Brief Summary:
The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2/3 Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
Actual Study Start Date: March 26, 2021
Estimated Primary Completion Date: December 15, 2027
Estimated Study Completion Date: December 15, 2027
Arms:
- Active Comparator: BHV-3500 200mg
- Placebo Comparator: Placebo 200mg
- Active Comparator: BHV-3500 100mg
- Placebo Comparator: Placebo 100mg
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 1440 |
| Actual Study start date | 26 March 2021 |
| Estimated study completion date | 15 December 2027 |