N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07729462

Registry updated: 2026-10-14
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

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.

Eligibility criteria

Inclusion Criteria: * Male or female participants ≥18 years of age. * Diagnosis of chronic migraine, with or without aura, according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria. * History of migraine for at least 1 year before screening. * Migraine onset before 50 years of age and chronic migraine onset before 65 years of age. * Migraine attacks lasting 4 to 72 hours when untreated or unsuccessfully treated. * During the 3 months prior to screening, an average of: * ≥15 monthly headache days (MHDs), * including ≥8 monthly migraine days (MMDs), * and ≥1 non-headache day per month. * Completion of the Observation Phase and fulfillment of all protocol-defined eligibility requirements prior to randomization. * Willing and able to comply with study procedures, including completion of the electronic diary. Exclusion Criteria: * Prior use of rimegepant for migraine prevention. * History of treatment failure of: * 2 gepants, or * 2 CGRP-targeting biologics, or * 1 gepant and ≥1 CGRP-targeting biologic. * Failure of \>4 migraine preventive medications, including at least 2 with different mechanisms of action. * Any medical or psychiatric condition, or clinically significant laboratory abnormality, that in the investigator's judgment may increase risk to the participant or interfere with study participation or interpretation of results. This includes, but is not limited to, uncontrolled hypertension or a history of Raynaud's phenomenon. * Pregnant, breastfeeding, planning to become pregnant, or planning to initiate breastfeeding during the study. * Positive amphetamine screening result unless attributable to prescribed stimulant therapy that has been stable for at least 3 months prior to Visit 1 and is expected to remain stable throughout study participation. * Use of investigational products or participation in another clinical study within protocol-defined exclusion windows. * Any other condition that, in the opinion of the investigator or sponsor, would make study participation unsafe or compromise study conduct.

Conditions

Preventive Treatment of Migraine

Locations

  • Clinical Endpoints — Scottsdale, Arizona, United States
  • Hope Clinical Research — Canoga Park, California, United States
  • Neuro-Pain Research Center — Fresno, California, United States
  • Clinical Research Institute — Los Angeles, California, United States
  • Neurology Offices of South Florida PLLC — Boca Raton, Florida, United States
  • Conquest Research-Winter Park — Winter Park, Florida, United States
  • Josephson Wallack Munshower Neurology,PC — Indianapolis, Indiana, United States
  • Collective Medical Research — Overland Park, Kansas, United States
  • New England Regional Headache Center, Inc. — Worcester, Massachusetts, United States
  • Michigan Headache & Neurological Institute — Ann Arbor, Michigan, United States
  • StudyMetrix Research — City of Saint Peters, Missouri, United States
  • Papillion Research Center / Avacare — Papillion, Nebraska, United States
  • Upstate Clinical Research Associates, LLC — Williamsville, New York, United States
  • Hightower Clinical — Oklahoma City, Oklahoma, United States
  • Clinical Neuroscience Solutions, LLC. — Memphis, Tennessee, United States
  • FutureSearch Trials of Neurology — Austin, Texas, United States
  • Austin Clinical Trial Partners — Austin, Texas, United States
  • FutureSearch Trials of Dallas — Dallas, Texas, United States
  • Highland Clinical Research — Salt Lake City, Utah, United States
  • Shaare Zedek Medical Center — Jerusalem, Jerusalem, Israel
  • Sourasky Medical Center — Tel Aviv, Israel
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record