NCT05810038

A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Chinese Participants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 787 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about the effects of Rimegepant to help prevent migraine. This study is seeking for participants who: * Are male and female of 18 years of age or older. * Have at least 1 year history of migraine . * Did not take any medication for migraine before the start of this study. The study will go on for around 30 weeks, including 4 Phases and 11 Visits. Participants who are selected for the study will be randomly assigned to treatment groups. After which, the participants will enter a 12-week Double-blind Treatment (DBT) Phase. After finishing the DBT Phase, some selected participants may enter a 12-week Open-label Extension (OLE) Phase. Participants will come back to the study site at the end of Week 24 for the End of Treatment (EOT) Visit. There will be a follow-up Week 2 Visit around 14 days after the EOT visit. Participants will be asked to take 1 tablet of study medicine every other calendar day. This need to be followed regardless of whether they have a migraine on that day or not. During the OLE Phase only, if a participant has a migraine on a non-scheduled dosing day, they may take 1 tablet of Rimegepant orally disintegrating tablet (ODT) as acute treatment for their migraine, if needed, with a maximum of 1 tablet of Rimegepant per calendar day. The study team will look at how each participant is doing with the study treatment during the regular visits at the study clinic.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Rimegepant	Rimegepant
DRUG	Placebo	matching placebo

Timeline

• Start date: 2023-05-15
• Primary completion: 2025-08-25
• Completion: 2025-12-10
• First posted: 2023-04-12
• Last updated: 2026-01-14

Locations

49 sites across 1 country: China

Regulatory

• FDA-regulated drug study