Trials / Recruiting
RecruitingNCT05156398
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 640 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rimegepant | Rimegepant 75mg or 50mg (2 X 25mg) ODT |
| DRUG | Placebo | Matching placebo 75mg or 50mg (2 X 25mg) ODT |
Timeline
- Start date
- 2022-02-28
- Primary completion
- 2031-11-29
- Completion
- 2032-11-27
- First posted
- 2021-12-14
- Last updated
- 2026-04-16
Locations
90 sites across 7 countries: United States, Canada, France, Italy, Japan, Poland, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05156398. Inclusion in this directory is not an endorsement.