Every other day, rimegepant was better at preventing migraines than placebo in adults with a history of migraine headache. This is evident from the results of studies published in the Lancet.
Study researchers attempted to compare the effectiveness of rimegepant with placebo for preventive migraine treatment in this multicenter, double-blind, randomized phase 2/3 study (ClinicalTrials.gov Identifier: NCT03732638). Study researchers enrolled 747 adults with a history of migraines for at least 1 year (mean age 41.2 years) at 92 locations 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). Active treatment and placebo were administered every other day for a total of 12 weeks during the double-blind treatment phase.
For the primary endpoint of the study, the researchers assessed the change in the average number of migraine days per month over the last 4 weeks or weeks 9 to 12 of the double-blind treatment period from the 4-week observation period. They examined safety in participants who received at least 1 study drug dose (n = 741).
The mean double-blind treatment time was 11.2 weeks for rimegepant and 11.1 weeks for placebo. Rimegepant treatment was superior to placebo in terms of the change in the mean number of migraine days per month from weeks 9 to 12 (-4.3) [95% CI, -4.8 to -3.9] vs -3.5 days [95% CI, -4.0 to -3.0], respectively. The mean least squares difference between rimegepant and placebo groups was -0.8 days (95% CI, -1.46 to -0.20; P = 0.0099).
Approximately 36% of the patients in the rimegepant arm and 36% of the participants in the placebo group had 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. No deaths were reported in the study.
The limitations of the study included the short duration, the relatively small sample size, and the lack of an active comparator arm.
The study’s researchers concluded that their “results provide evidence that oral CGRP receptor antagonists can offer a targeted new approach to migraine prevention”. They added that “They are also showing, for the first time, that orally administered rimegepant 75 mg is effective as a preventive treatment over 12 weeks. Rimegepant has shown effectiveness both as an acute treatment and as a preventive treatment for migraines. ”
Disclosure: Several authors of the study have stated that they are part of the pharmaceutical industry. For a full list of the authors’ information, see the original reference.
Croop R., Lipton RB, Kudrow D. et al. Oral rimegepant for the preventive treatment of migraines: a randomized, double-blind, placebo-controlled phase 2/3 study. Published online 15 December 2020. Lancet. doi: 10.1016 / S0140-6736 (20) 32544-7