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Study of Rimegepant for Preventing Chronic Migraine

This study is looking at how well a medicine called rimegepant works to prevent chronic migraine in adults. Rimegepant is already approved for other types of migraine. Here, we're testing if taking 75 mg of rimegepant every day can reduce the number of migraine days you experience. About 400 adults with chronic migraine, aged 18 and older, can join. You must have had migraines for at least a year and chronic migraine before age 65. The main goal is to see if rimegepant is better than a placebo (a pill with no medicine) at lowering your monthly migraine days over 12 weeks. The study is currently unclear on its status.

Study design
This is a Phase 3, randomized, double-blind, placebo-controlled study involving about 400 participants. You would be randomly assigned to receive either rimegepant or a placebo.
What's involved
You would have a 28-day observation period, then take either rimegepant or placebo once daily for 12 weeks. You would also record migraine information in an electronic diary and have various safety and effectiveness checks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 weeks. Participants may also enter a 12-week open-label extension phase.

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NCT07729462

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

Not Yet Recruiting
PHASE3Ages 18+InterventionalPrevention
Pfizer
~400 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:RimegepantPlacebo

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase
Measured over 12 Weeks

Conditions

Preventive Treatment of Migraine

Explore related trials

Chronic Migraine

Where it's being run

2 sites across 2 states
California1
Florida1

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase12 Weeks

    Change from the Observation Phase in the number of monthly migraine days (MMDs) over the 12-week Double-Blind Treatment Phase. Monthly migraine days will be assessed using participant-reported electronic diary data.