Actively Recruiting
Phase 3 Study of Rimegepant for Intermittent Prevention of Menstrual Migraine in Women Aged 18 to 45
Led by Pfizer · Updated on 2026-07-09
723
Participants Needed
123
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of rimegepant for intermittent prevention of menstrual migraine in women aged 18 to 45 who experience migraine attacks related to their menstrual cycle. This Phase 3, double-blind, randomized study compares rimegepant with placebo to assess its efficacy and safety during the peri-menstrual period. The study focuses on migraine frequency and severity in women with a history of menstrual migraine and regular menstrual cycles. Participants receive either rimegepant 75 mg orally disintegrating tablets for 7 days during each peri-menstrual period or a matching placebo, along with standard care for acute migraine treatment as needed. The study treatment cycles are repeated over 5 menstrual cycles in the double-blind treatment phase. The study also includes an acute treatment dosing option with rimegepant as needed. During the study, participants will be monitored for changes in the number of migraine and headache days, use of migraine medications, and functional disability related to migraine. Cognitive function is also assessed. Researchers will conduct evaluations over 5 months, covering 5 menstrual cycles, and measure outcomes related to migraine frequency and severity during the peri-menstrual period. Safety and tolerability will be closely monitored throughout the study.
CONDITIONS
Brief Title
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
Research Team
P
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