NCT07729462RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 26 Aug 2026
- Primary completion date
- 21 Oct 2028
- Lead sponsor
- Pfizer
- Diseases
- Migraine
- NCT number
- NCT07729462
- EU CT number
- 2026-525295-25-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 26 Aug 2026 to the primary completion date, 21 Oct 2028
- 21 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of rimegepant for migraine prevention.
- 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.
Other illness
- 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 other condition that, in the opinion of the investigator or sponsor, would make study participation unsafe or compromise study conduct.
Lab values
- 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.
Other
- Pregnant, breastfeeding, planning to become pregnant, or planning to initiate breastfeeding during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Michigan Headache & Neurological Institute Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| FutureSearch Trials of Neurology Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Austin Clinical Trial Partners Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Neurology Offices of South Florida PLLC Coordinator of this site? Confirm its status | Boca Raton | United States | Recruiting |
| Hope Clinical Research Coordinator of this site? Confirm its status | Canoga Park | United States | Recruiting |
| StudyMetrix Research Coordinator of this site? Confirm its status | City of Saint Peters | United States | Recruiting |
| FutureSearch Trials of Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Neuro Pain Research Center Coordinator of this site? Confirm its status | Fresno | United States | Recruiting |
| Josephson Wallack Munshower Neurology, PC Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Clinical Research Institute Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Clinical Neuroscience Solutions, LLC. Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Hightower Clinical Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Collective Medical Research Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| Papillion Research Center/Avacare Coordinator of this site? Confirm its status | Papillion | United States | Recruiting |
| Highland Clinical Research Coordinator of this site? Confirm its status | Salt Lake City | United States | Not yet recruiting |
| Clinical Endpoints Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Upstate Clinical Research Associates, LLC Coordinator of this site? Confirm its status | Williamsville | United States | Not yet recruiting |
| Conquest Research-Winter Park Coordinator of this site? Confirm its status | Winter Park | United States | Recruiting |
| New England Regional Headache Center, Inc. Coordinator of this site? Confirm its status | Worcester | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.