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

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started
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Trial flagged as At Risk
Primary completion moved at least 39 days later Sep 12, 2028 → Oct 21, 2028
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Record History

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  1. Study sites: 19 to 21
  2. Trial sites expanded: 4 → 19 locations
  3. Recruitment opened Show 6 more changesShow less
    • Primary completion pushed from Sep 12, 2028 to Oct 21, 2028
    • Study completion pushed from Dec 11, 2028 to Jan 19, 2029
    • Start date changed from estimate of Jul 29, 2026 to Aug 26, 2026
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 6 of 7 entries
    • Site details revised at 4 of 4 sites
  4. Study sites: 2 to 4v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
436 trials monitored
See 32 trials at risk
Migraine
482 trials monitored
See 26 trials at risk
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.
Trial Details
NCT Number NCT07729462
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Preventive Treatment of Migraine
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov