Rimegepant effective for migraine prevention: Lancet
USA: Rimegepant, when taken every other day, can help in the prevention of migraine, shows a recent phase 2/3 trial. The findings of the study, published in The Lancet, showed that the use of rimegepant had no unexpected or serious safety issues and its tolderability was same as that of placebo.
Rimegepant is an oral calcitonin gene-related peptide receptor (CGRP) antagonist that has shown safety and efficacy in the acute treatment of migraine. Robert Croop, Biohaven Pharmaceuticals, New Haven, USA, and colleagues aimed to compare the efficacy of rimegepant with placebo for preventive treatment of migraine.
For the purpose, the researchers performed a multicentre, phase 2/3, randomised, double-blind, placebo-controlled trial at 92 sites in the USA. It recruited 1591 participants with at least a 1-year history of migraine. After a 4-week observation period, 747 were randomized to receive either oral rimegepant 75 mg or matching placebo every other day for 12 weeks (double-blind treatment phase).
The primary efficacy endpoint was change from the 4-week observation period in the mean number of migraine days per month in the last 4 weeks of the double-blind treatment phase (weeks 9–12). Those participants who received at least one dose of their assigned study medication plus had 14 days or more of data in the observation period and 14 days or more of data for at least one 4-week interval during the double-blind treatment phase were analysed for efficacy. Those who received at least one dose of study medication were analysed for safety.
Key findings of the study include:
- 695 participants were included in the analysis for efficacy, of whom 348 were assigned rimegepant and 347 were allocated placebo.
- Rimegepant was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9–12.
- The change from the observation period in mean number of migraine days per month during weeks 9–12 was −4·3 days with rimegepant and −3·5 days with placebo.
- 741 participants received study medication and were included in the safety analysis.
- 36% of 370 patients who received rimegepant reported an adverse event, compared with 36% of 371 who received placebo.
- Seven (2%) participants who received rimegepant and four (1%) who received placebo discontinued the study due to an adverse event; no patients died.
"Taken every other day, rimegepant was effective for preventive treatment of migraine. Tolerability was similar to that of placebo, and no unexpected or serious safety issues were noted," concluded the authors.
"Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial," is published in the journal Lancet.