Rimegepant Shows Efficacy and Safety in Treating Acute Migraine
More subjects treated with rimegepant were pain-free 2 hours after dose than subjects treated with placebo.
|The following article is part of conference coverage from the 2018 American Headache Society Annual Scientific Meeting in San Francisco, California. Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AHS 2018.|
SAN FRANCISCO — Rimegepant is a safe and efficacious pharmacological treatment of acute migraine in adults. This research was presented at the American Headache Society's 60th Annual Scientific Meeting, held June 28–July 1, 2018, in San Francisco, California.
This study (ClinicalTrials.gov Identifier: NCT03235479) included results from 1084 adults aged at least 18 years, 543 of whom were given rimegepant (75 mg oral tablet) and 541 of whom were given placebo.
More subjects treated with rimegepant were pain-free 2 hours after dose than subjects treated with placebo (19.2% vs 14.2%; P =.0298) and reported greater rates of pain relief (56.0% vs 45.7%; P =.0006).
Additionally, rimegepant-treated subjects were less likely to experience their most bothersome symptom at 2 hours post-dose (36.6% vs 27.7%; P =.0016), and showed higher rates of normal function (P <.0001).
For 2 to 48 hours after dose with rimegepant, subjects experienced sustained pain freedom (P =.013) and pain relief (P =.0003).
Adverse events in rimegepant 75 mg and placebo groups consisted mainly of nausea (0.9% vs 1.1%) and dizziness (0.7% vs 0.4%), though 2 rimegepant subjects experienced serious adverse events compared with 1 in the placebo group.
Rimegepant was not found to be related to the serious adverse events, as the events occurred before dose.
Participants in this double-blind, randomized study had experienced ICHD 3-beta migraine for a minimum of 1 year, and received 3 to 28 days of screening before randomization. The primary end points included 2-hour-post-dose freedom from pain and most bothersome symptom, and adverse events, electrocardiographs, measurements, standard lab tests, and vital signs were included in safety evaluations.
The study researchers conclude that “[significant] and durable clinical effects were seen with a single dose of rimegepant across multiple outcome measures, including pain freedom, freedom from [most bothersome symptom], pain relief, and recovery of normal function.”
Lipton R, Conway C, Stock E, et al. Efficacy, safety, and tolerability of rimegepant 75 mg, an oral CGRP receptor antagonist, for the acute treatment of migraine: Results from a double-blind, randomized, placebo-controlled trial, study 301. Presented at: 2018 American Headache Society Annual Scientific Meeting. June 28-July 1, 2018; San Francisco, CA. Abstract 492562.For more coverage of AHS 2018, click here.