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

NCT ID: NCT07729462
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Pfizer
Conditions: Preventive Treatment of Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 400 participants (Estimated).

What is being studied

Drug: Placebo
Drug: Rimegepant
Intervention: rimegepant sulfate

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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.

Study locations

19 study locations are listed.

Recruiting site status is explicitly provided for 19 locations; 12 are listed as Recruiting.

Countries: Israel, United States

Jerusalem, Israel: 1
Arizona, United States: 1
California, United States: 3
Florida, United States: 2
Indiana, United States: 1
Massachusetts, United States: 1
Michigan, United States: 1
Missouri, United States: 1
Nebraska, United States: 1
Oklahoma, United States: 1
Tennessee, United States: 1
Texas, United States: 3
Utah, United States: 1

Sample of listed locations

Sourasky Medical Center — Tel Aviv, 6423906, Israel — Recruiting
Clinical Endpoints — Scottsdale, Arizona, 85258, United States — Recruiting
Hope Clinical Research — Canoga Park, California, 91303, United States — Recruiting
Neuro-Pain Research Center — Fresno, California, 93710, United States — Recruiting
Clinical Research Institute — Los Angeles, California, 90048, United States — Recruiting
Neurology Offices of South Florida PLLC — Boca Raton, Florida, 33428, United States — Recruiting
StudyMetrix Research — City of Saint Peters, Missouri, 63303, United States — Recruiting
Papillion Research Center / Avacare — Papillion, Nebraska, 68046, United States — Recruiting
Hightower Clinical — Oklahoma City, Oklahoma, 73120, United States — Recruiting
Austin Clinical Trial Partners — Austin, Texas, 78737, United States — Recruiting
FutureSearch Trials of Neurology — Austin, Texas, 78731, United States — Recruiting
FutureSearch Trials of Dallas — Dallas, Texas, 75251, United States — Recruiting
Shaare Zedek Medical Center — Jerusalem, Jerusalem, 9103102, Israel — Not yet recruiting
Conquest Research-Winter Park — Winter Park, Florida, 32789, United States — Not yet recruiting
Josephson Wallack Munshower Neurology,PC — Indianapolis, Indiana, 46256, United States — Not yet recruiting
New England Regional Headache Center, Inc. — Worcester, Massachusetts, 01609, United States — Not yet recruiting
Michigan Headache & Neurological Institute — Ann Arbor, Michigan, 48104, United States — Not yet recruiting
Clinical Neuroscience Solutions, LLC. — Memphis, Tennessee, 38119, United States — Not yet recruiting
Highland Clinical Research — Salt Lake City, Utah, 84124, United States — Not yet recruiting

Study details

Start date: August 26, 2026
Primary completion date: October 21, 2028
Completion date: January 19, 2029
First posted: July 27, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07729462
Registry last updated: September 25, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT07729462 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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