Daily rimegepant for chronic migraine prevention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, multicenter, double-blind study in adults with chronic migraine. After an initial observation period, participants are randomized to receive either daily rimegepant 75 mg or placebo for 12 weeks, followed by an open-label extension where all participants take rimegepant. Participants track migraines with an electronic diary and undergo safety monitoring. If they complete the double-blind phase, they may enter the open-label phase with ongoing access to rimegepant and the option to take an extra dose for breakthrough attacks. The study aims to assess reduction in monthly migraine days and several secondary outcomes such as quality of life, disability, and work productivity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Endpoints
  Scottsdale, Arizona, United States Recruiting
• Hope Clinical Research
  Canoga Park, California, United States Recruiting
• Neuro-Pain Research Center
  Fresno, California, United States Recruiting
• Clinical Research Institute
  Los Angeles, California, United States Recruiting
• Neurology Offices of South Florida PLLC
  Boca Raton, Florida, United States Recruiting
• Conquest Research-Winter Park
  Winter Park, Florida, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.