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NCT07609914PHASE4Recruiting

A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine

Pfizer

Start Date

5/28/2026

Completion Date

5/15/2028

Summary

Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack. The primary purpose of this study is to evaluate the safety and tolerability of redosing of rimegepant when taken for the acute treatment of a migraine attack, as it is possible that some patients may benefit from a second dose of rimegepant in this setting.

Detailed Description

To evaluate the safety and tolerability of rimegepant 75 mg ODT when redosed due to residual pain or headache relapse

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion: * Eligible participants include adult participants aged 18 years of age or older with a minimum 1-year history of migraine (with or without aura) consistent with International Classification of Headache Disorders, 3rd Edition * Eligible participants must be currently using acute migraine treatment in accordance with the local label and have all of the following on average across the 12 weeks prior to the Screening Visit and, during the first 28 days of the observation phase (OP): (1) 6-14 monthly migraine days (MMDs); (2) \<15 monthly headache days (MHDs) (migraine or non-migraine); and (3) \<7 monthly non-migraine headache days. Exclusion: * Participants with headaches occurring ≥15 days per month (migraine or non-migraine) on average across the 12 weeks prior to the Screening Visit and ≥7 non-migraine headache days per month on average across the 12 weeks prior to the Screening Visit would not be eligible.

Interventions

DRUG

Rimegepant

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Conditions

Acute Treatment of Migraine

Locations

Hope Clinical Research

Canoga Park, California 91303

United States

Neurology Offices of South Florida

Boca Raton, Florida 33428

United States

Brainstorm Research

Miami, Florida 33176

United States

Clinical Neuroscience Solutions

Orlando, Florida 32801

United States

New England Regional Headache Center

Worcester, Massachusetts 01609

United States

Michigan Headache & Neurological Institute

Ann Arbor, Michigan 48104

United States

Proven Endpoints, LLC

Ridgeland, Mississippi 39157

United States

Headache Wellness Center

Greensboro, North Carolina 27405

United States

FutureSearch Trials of Neurology

Austin, Texas 78731

United States

FutureSearch Trials of Dallas

Dallas, Texas 75251

United States

MedStar Health - Department of Neurology

McLean, Virginia 22101

United States