Oral rimegepant an effective preventive for migraine — clinical trial

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Rimegepant was effective for preventive treatment of migraine, found a randomised, double-blind, placebo-controlled phase 2/3 trial, published in The Lancet.

Migraine affects 15% of the world’s population and ranks among the most burdensome disorders and has enormous individual and socioeconomic consequences. It is especially bothersome in people with frequent episodic and chronic migraine, who typically need prophylactic treatment.

Rimegepant (Nurtec ODT), the first calcitonin gene–related peptide (CGRP) receptor antagonist approved in the United States for the acute treatment of migraine, may help prevent migraine headaches as well.

In a phase 2/3 study, oral rimegepant was superior to placebo in reducing monthly migraine days. About half of adults who took rimegepant experienced a 50% or greater reduction in the number of days of moderate to severe migraines per month.

“This is the first time an oral CGRP migraine treatment has shown dual efficacy in both the acute and preventive treatment of migraine,” study coauthor Professor Peter Goadsby of  King’s College London and the University of California, Los Angeles, said in a news release.

“With this flexibility, these therapies are truly disruptive and change the treatment paradigm for people living with migraine,” he added.

In The Lancet, the researchers report a randomised, double-blind, placebo-controlled phase 2/3 trial that assessed the efficacy and safety of rimegepant for migraine prevention in patients (mean age 41·2 years [SD 13·1]), of whom 83% were women and 82% were white, with episodic and chronic migraine. After a 4-week observation period, patients were randomly allocated either oral rimegepant every other day (n=373) or placebo (n=374) for the next 12 weeks.

 

Study details

Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial

Robert Croop, Prof Richard B Lipton, David Kudrow, David A Stock, Lisa Kamen, Charles M Conway, et al.

The Lancet, 15 December 15, 2020

 

Abstract

Background
Rimegepant is a calcitonin gene-related peptide receptor antagonist that has shown efficacy and safety in the acute treatment of migraine. We aimed to compare the efficacy of rimegepant with placebo for preventive treatment of migraine.

Methods
We did a multicentre, phase 2/3, randomised, double-blind, placebo-controlled trial at 92 sites in the USA. Adults with at least a 1-year history of migraine were recruited. After a 4-week observation period, eligible participants were randomised using an interactive web response system to 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). Participants who received at least one dose of their assigned study medication and who 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. This study is registered with ClinicalTrials.gov, NCT03732638.

Findings
Between Nov 14, 2018, and Aug 30, 2019, 1591 participants were recruited and assessed for eligibility, of whom 747 were randomly allocated either rimegepant (n=373) or placebo (n=374). 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 (95% CI –4·8 to –3·9) with rimegepant and −3·5 days (–4·0 to –3·0) with placebo (least squares mean difference −0·8 days, 95% CI −1·46 to −0·20; p=0·0099). 741 participants received study medication and were included in the safety analysis. 133 (36%) of 370 patients who received rimegepant reported an adverse event, compared with 133 (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.

Interpretation
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.

Funding
Biohaven Pharmaceuticals

 

The Lancet study (Subscription required)

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