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NCT07729462From ClinicalTrials.govRecruiting

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

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, RANDOMIZED, 2-ARM STUDY TO INVESTIGATE THE PREVENTION OF CHRONIC MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN PARTICIPANTS 18 YEARS OF AGE OR OLDER

  • Preventive Treatment of Migraine

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Pfizer
Enrolment target
400
Started
26 August 2026
Main results due
21 October 2028
Study sites
19
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(19)

  • Clinical Endpoints

    Scottsdale, Arizona, United States

    Recruiting

  • Hope Clinical Research

    Canoga Park, California, United States

    Recruiting

  • Neuro-Pain Research Center

    Fresno, California, United States

    Recruiting

  • Clinical Research Institute

    Los Angeles, California, United States

    Recruiting

  • Neurology Offices of South Florida PLLC

    Boca Raton, Florida, United States

    Recruiting

  • Conquest Research-Winter Park

    Winter Park, Florida, United States

    Not yet recruiting

  • Josephson Wallack Munshower Neurology,PC

    Indianapolis, Indiana, United States

    Not yet recruiting

  • New England Regional Headache Center, Inc.

    Worcester, Massachusetts, United States

    Not yet recruiting

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan, United States

    Not yet recruiting

  • StudyMetrix Research

    City of Saint Peters, Missouri, United States

    Recruiting

  • Papillion Research Center / Avacare

    Papillion, Nebraska, United States

    Recruiting

  • Hightower Clinical

    Oklahoma City, Oklahoma, United States

    Recruiting

  • Clinical Neuroscience Solutions, LLC.

    Memphis, Tennessee, United States

    Not yet recruiting

  • FutureSearch Trials of Neurology

    Austin, Texas, United States

    Recruiting

  • Austin Clinical Trial Partners

    Austin, Texas, United States

    Recruiting

  • FutureSearch Trials of Dallas

    Dallas, Texas, United States

    Recruiting

  • Highland Clinical Research

    Salt Lake City, Utah, United States

    Not yet recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, Israel

    Not yet recruiting

  • Sourasky Medical Center

    Tel Aviv, Israel

    Recruiting

Showing 19 of 19 sites. 12 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07729462. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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