Every-other-day rimegepant prevented migraine better than placebo in adults with a history of migraine headaches, according to study results published in the Lancet.
Study researchers sought to compare the efficacy of rimegepant with placebo for preventive migraine treatment in this multicenter, phase 2/3, double-blind, randomized trial (ClinicalTrials.gov Identifier: NCT03732638). Study researchers enrolled 747 adults with a history of migraine for at least 1 year (mean age, 41.2) across 92 sites in the United States. Participants in the study were randomly assigned to either 75 mg oral rimegepant (n=373) or a matching placebo (n=374). The active treatment and placebo were administered every other day for a total of 12 weeks during the double-blind treatment phase.
For the study’s primary endpoint, the researchers assessed the change from the 4-week observation period in the average number of migraine days per month in the last 4 weeks, or weeks 9 through 12, of the double-blind treatment phase. They examined safety in participants who received at least 1 study medication dose (n=741).
The average time spent on the double-blind treatment was 11.2 weeks for rimegepant and 11.1 weeks for placebo. Treatment with rimegepant was superior to treatment with placebo in terms of the change in the mean number of migraine days per month during weeks 9 through 12 (-4.3 [95% CI, -4.8 to -3.9] vs -3.5 days [95% CI, -4.0 to -3.0], respectively. The least squares mean difference between rimegepant and placebo groups was -0.8 days (95% CI, -1.46 to -0.20; P =.0099).
Approximately 36% of patients in the rimegepant arm and 36% of participants in the placebo group experienced an adverse event (AE) during the observation period. A total of 7 patients treated with rimegepant and 4 patients treated with placebo discontinued the study because of an AE. There were no deaths reported in the study.
Limitations of the study included its short duration, relatively small sample size, and the lack of an active comparator arm.
The study researchers concluded that their “findings add to evidence that oral CGRP receptor antagonists can provide a targeted novel approach to migraine prevention.” They added that “they also show, for the first time, that orally administered rimegepant 75 mg is effective as a preventive treatment over 12 weeks. Thus, rimegepant has shown efficacy as both an acute treatment and a preventive treatment for migraine.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Published online December 15, 2020. Lancet. doi:10.1016/S0140-6736(20)32544-7