NCT05509400

Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

BHV3000-406 (C4951004): A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 632 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).

Detailed description

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Rimegepant	DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)
DRUG	Placebo	DB Phase: matching placebo
DRUG	Rimegepant	OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines

Timeline

• Start date: 2022-10-18
• Primary completion: 2025-03-10
• Completion: 2025-06-10
• First posted: 2022-08-22
• Last updated: 2025-07-18

Locations

93 sites across 15 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Mexico, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study