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This study evaluates the efficacy and safety of the drug Rimegepant in preventing episodic migraine attacks, comparing different dosing regimens (daily and every other day) with placebo. It enrolled people with at least a 1-year history of episodic migraine who had 4-14 migraine attacks per month over the previous 3 months. The study was conducted in Phase 4 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1\) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following: 1. Age of onset of migraines prior to 50 years of age 2. Migraine attacks, on average, lasting 4-72 hours if untreated 3. Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol Exclusion Criteria: 1. Sex and Reproductive Status: 1. WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug 2. Women who are pregnant or breastfeeding 3. Women with a positive pregnancy test at screening or prior to study drug administration 2. Prohibited Medications: 1. Use of prophylactic migraine medication within 30 days prior to the Screening Visit. 2. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit. 3. Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit. 4. Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit. 5. Subjects taking a prohibited medication as defined per protocol