TitleRimegepant Effecitve for the Preventive Treatment of Migraine
By Erika Powers
VIRTUAL -- April 27, 2021 -- The oral small molecule CGRP receptor antagonist rimegepant was effective for preventing migraine in a phase 3 randomised clinical trial, with tolerability similar to placebo, researchers reported at the Virtual 2021 Annual Meeting of the American Academy of Neurology (AAN).
“Oral rimegepant 75 mg taken every other day was effective for the preventive treatment of migraine, with no unexpected or serious safety issues,” said Robert Croop, MD, Biohaven Pharmaceuticals, New Haven, Connecticut. “Preventive efficacy was observed within the first week of treatment.”
The study (NCT03732638) enrolled adults with a history of 4 to 18 monthly migraine attacks of moderate to severe pain intensity. After a 4-week observation period, eligible subjects were randomised to placebo (n = 347) or oral rimegepant 75 mg (n = 348) every other day for 12 weeks.
The patients had a mean age of 41.2 years, 82.7% were female, and 81.5% were white.
Patients who were randomised to receive rimegepant had a change in mean monthly migraine days -- the primary endpoint -- of -4.3 days at weeks 9 to 12, compared with -3.5 days among patients randomised to placebo (P = .0099).
In addition, more patients in the rimegepant arm achieved a ≥50% reduction in mean number of moderate or severe monthly migraine days during weeks 9 to 12 (49.1% vs 41.5%; P = .0438).
“These preventive effects, along with previously established acute treatment efficacy, suggest that rimegepant may provide a new approach to treat migraine in an adaptive way, depending on an individual’s treatment needs from acute to prevention,” said Dr. Croop.
The incidence of adverse events (AEs) was similar in the rimegepant and placebo groups (35.9% vs 35.8%). The most common AEs in both groups, respectively, were nasopharyngitis (3.5% vs 2.4%), nausea (2.7% vs 0.8%), urinary tract infection (2.4% vs 2.2%), and upper respiratory tract infection (2.2% vs 2.7%). Four patients in the rimegepant group and 2 patients in the placebo group had transaminases >3x the upper limit of normal.
[Presentation title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for the Preventive Treatment of Migraine]