RecruitingPreventive Treatment of Migraine

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

Eligible age

18+ yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

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.

Sponsor: Pfizer

You may qualify if…

✓ 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),

You may not qualify if…

✕ 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.