Trials / Recruiting
RecruitingNCT04649242
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,100 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rimegepant/BHV3000 | BHV3000 (rimegepant) 75 mg or 50 mg ODT |
| DRUG | Matching placebo | Matching 75 mg or 50 mg ODT placebo |
Timeline
- Start date
- 2021-01-15
- Primary completion
- 2029-01-09
- Completion
- 2029-01-09
- First posted
- 2020-12-02
- Last updated
- 2026-04-16
Locations
246 sites across 9 countries: United States, Canada, China, Japan, Mexico, Poland, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04649242. Inclusion in this directory is not an endorsement.