Recruiting
Phase 3

Rimegepant

Sponsor:

Pfizer

Code:

NCT07729462

Conditions

Preventive Treatment of Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rimegepant

Placebo

Study Details

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.

Conditions

Preventive Treatment of Migraine

Study ID

NCT07729462

Start date

Aug 26, 2026

Status verified date

Sep, 2026

Completion date

Jan 19, 2029

Anticipated

Primary completion date

Oct 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Rimegepant 75 mg orally disintegrating tablet (ODT) once daily

Participants will receive rimegepant 75 mg orally disintegrating tablet (ODT) once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and 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 migraine attacks, up to 10 doses per month.

placebo comparator: Matching placebo once daily for 12 weeks during the double-blind treatment phase

Participants will receive matching placebo once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and 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 migraine attacks, up to 10 doses per month.

Interventions

Rimegepant

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

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.

Primary outcome measure

  • Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase [ Time Frame: 12 Weeks ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Hope Clinical Research

Recruiting

Canoga Park, California, United States, 91303

Neurology Offices of South Florida PLLC

Recruiting

Boca Raton, Florida, United States, 33428

More Information

Sponsor

Pfizer

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • Migraine Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Pfizer on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.