CompletedPhase 4

Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

United States1,415 participantsStarted 2022-03-04

Plain-language summary

The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age of onset of migraines prior to 50 years of age
✓. Migraine attacks, on average, lasting 4-72 hours if untreated
✓. 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

✕. Sex and Reproductive Status:
✕. 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
✕. Women who are pregnant or breastfeeding
✕. Women with a positive pregnancy test at screening or prior to study drug administration
✕. Prohibited Medications:
✕. Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
✕. 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.
✕. 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.

What they're measuring

Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)

Timeframe: Observation phase (from 31 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12])

Trial details

NCT IDNCT05217927

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-22

Results submitted2025-10-22

View on ClinicalTrials.gov More Migraine trials