A Study to Learn About the Study Medicine Called Rimegepant in Adults When Used for the Prevention of Chronic Migraine

Conditions

• Preventive Treatment of Migraine

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rimegepant — DRUG
  Rimegepant 75 mg orally disintegrating tablet (ODT) administered once daily during the 12-week double-blind treatment phase. Participants who enter the 12-week open-label extension phase will receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough headache attacks, up to 10 doses per month.
• Placebo — DRUG
  Matching placebo orally disintegrating tablet administered once daily during the 12-week double-blind treatment phase. Participants who enter the 12-week open-label extension phase will receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough headache attacks, up to 10 doses per month.

Study Details

Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day. This study evaluates once daily rimegepant for the preventive treatment of chronic migraine. After a 28-day observation period without study intervention, eligible participants will be randomized in a 1:1 ratio to receive either rimegepant 75 mg orally disintegrating tablet (ODT) or matching placebo once daily for 12 weeks under double-blind conditions. Participants who remain eligible at the end of the double-blind treatment phase will enter a 12-week open-label treatment period, during which all participants will receive open-label rimegepant 75 mg once daily. During this period, participants may also take an additional rimegepant tablet for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. A 28-day follow-up period completes the approximately 32-week study. The primary objective of the study is to determine whether once-daily rimegepant is more effective than placebo in reducing monthly migraine days relative to the observation period in adults with chronic migraine. Secondary objectives include evaluating differences between rimegepant and placebo in migraine responder rates, headache severity, acute migraine medication use, quality of life, work productivity, cognitive functioning, and safety and tolerability. Approximately 400 adults aged 18 years or older with a diagnosis of chronic migraine for at least 1 year will be enrolled at multiple study sites.

Key Dates

First listed

Jul 27, 2026

Start date

Jul 29, 2026

Status verified

Jul 2026

Primary completion

Sep 12, 2028

Completion

Dec 11, 2028

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Rimegepant 75 mg orally disintegrating tablet (ODT) once daily
  Participants will receive rimegepant 75 mg orally disintegrating tablet (ODT) once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month.
• Placebo Comparator: Matching placebo once daily for 12 weeks during the double-blind treatment phase
  Participants will receive matching placebo once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month.

Primary Outcome Measure

Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase [ Time Frame: 12 Weeks ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (2)

Find similar trials in Canoga Park, CA