NCT05518123

Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

A Phase 4, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With a History of Inadequate Response to Oral Preventive Medications

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 658 (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 for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Rimegepant	Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taken every other day during Double-blind Treatment (DBT) phase
DRUG	Placebo	Matching placebo with every other day dosing during DBT phase

Timeline

• Start date: 2022-11-07
• Primary completion: 2025-03-31
• Completion: 2025-07-08
• First posted: 2022-08-26
• Last updated: 2025-07-18

Locations

111 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Italy, Mexico, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study