NCT07729462 A Study to Learn About the Study Medicine Called Rimegepant in Adults When Used for the Prevention of Chronic Migraine
| NCT ID | NCT07729462 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | Preventive Treatment of Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-08-26 |
| Primary Completion | 2028-10-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2026-08-26 with a primary completion date of 2028-10-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07729462 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Preventive Treatment of Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07729462 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT07729462 currently recruiting?
Yes, NCT07729462 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07729462 trial being conducted?
This trial is being conducted at Scottsdale, United States, Canoga Park, United States, Fresno, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT07729462 clinical trial?
NCT07729462 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 400 participants.
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