Efficacy and Safety of Rimegepant 75 mg Oral Tablet, a CGRP Receptor Antagonist, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial
- PMID: 39070853
- PMCID: PMC11277999
- DOI: 10.2147/JPR.S453806
Efficacy and Safety of Rimegepant 75 mg Oral Tablet, a CGRP Receptor Antagonist, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial
Erratum in
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Erratum: Efficacy and Safety of Rimegepant 75 Mg Oral Tablet, a CGRP Receptor Antagonist, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial [Corrigendum].J Pain Res. 2024 Dec 3;17:4085-4086. doi: 10.2147/JPR.S499096. eCollection 2024. J Pain Res. 2024. PMID: 39650209 Free PMC article.
Abstract
Purpose: This study compared the efficacy, tolerability, and safety of rimegepant 75 mg oral tablet - a small molecule calcitonin-gene receptor peptide (CGRP) receptor antagonist - with placebo in the acute treatment of migraine.
Methods: This double-blind, randomized, placebo-controlled trial enrolled adults aged ≥18 years with at least a 1-year history of migraine. Participants randomized to rimegepant 75 mg oral tablet or placebo treated a single migraine attack of moderate or severe pain intensity. The coprimary endpoints, pain freedom and freedom from the most bothersome symptom ([MBS] nausea, photophobia, or phonophobia) at 2 hours postdose, were evaluated using Mantel-Haenszel risk estimation.
Results: Of the 1485 participants enrolled, 1162 (78.2%) were randomized to rimegepant (n = 582) or placebo (n = 580). Most participants (85.5%) were female; the population had a mean (SD) age of 41.6 (12.2) years and a history of 4.7 (1.8) migraine attacks per month. At 2 hours postdose, rimegepant-treated participants had higher pain freedom rates (19.2% [104/543] vs 14.2% [77/541]; risk difference 4.9; 95% confidence interval [CI] 0.5 to 9.3; P=0.0298) and MBS freedom rates (36.6% [199/543] vs 27.7% [150/541]; risk difference 8.9; 95% CI 3.4 to 14.4; P=0.0016) than placebo-treated participants. Rimegepant-treated participants also had higher rates of pain relief (56.0% [304/543] vs 45.7% [247/541]; risk difference 10.3; 95% CI 4.4 to 16.2, P=0.0006) at 2 hours postdose. The most common adverse events were nausea (0.9% [5/546] vs 1.1% [6/549]) and dizziness (0.7% [4/546] vs 0.4% [2/549]). No signal of drug-induced liver injury due to rimegepant was identified.
Conclusion: Rimegepant 75 mg oral tablet was effective in the acute treatment of migraine. Tolerability and safety were similar to placebo, with no evidence of hepatotoxicity.
Trial registration: Clinicaltrials.gov Identifier: NCT03235479.
Keywords: CGRP; acute; efficacy; migraine; rimegepant; safety; tablet.
Plain language summary
Researchers wanted to know if rimegepant 75 mg is effective and safe for the acute treatment of migraine. They gave half the participants rimegepant and half placebo and waited 2 hours. Then, they measured the percentages of participants whose headache and most bothersome migraine symptom besides pain (nausea, sensitivity to light or sound) were gone. They also measured side effects to make sure rimegepant is safe. The study included 1084 adults with migraine, 927 (86%) of whom were women. Two hours after taking the medicine: pain freedom was 19% with rimegepant and 14% with placebo. Freedom from the most bothersome symptom was 37% with rimegepant and 28% with placebo. Pain relief rates, defined as the transition from moderate or severe pain to pain that was mild or absent, occurred in 56% with rimegepant and 46% with placebo. The most common side effects were nausea and dizziness, which affected fewer than 1% of rimegepant patients. Rimegepant 75 mg was more effective than placebo for migraine, with similar tolerability and safety.
© 2024 Lipton et al.
Conflict of interest statement
Richard B. Lipton serves on the editorial board of Neurology and as senior advisor to Headache but is not paid for his roles on these journals. He has received research support from the NIH. He also receives support from the National Headache Foundation. He receives research grants from Allergan/AbbVie, Amgen, Dr. Reddy’s Laboratories, and Novartis. He has reviewed for the NIA and NINDS and serves as consultant, advisory board member, or has received honoraria from Allergan/AbbVie, Amgen, Avanir, Axsome, Biohaven, Biovision, BDSI, Boston Scientific, Cool Tech, Cult Health, Dr. Reddy’s Laboratories, electroCore, Eli Lilly, Genentech, Grifols, GlaxoSmithKline, LinPharma, Lundbeck, Manistee, Merck, Novartis, Pfizer, Satsuma, Teva, and Vedanta. He receives royalties from Wolff’s Headache (8th Edition, Oxford Press University, 2009) and Informa. He holds stock in Biohaven Pharmaceuticals and holds options in Axon, CoolTech, and Manistee. Robert Croop was an employee of Biohaven Pharmaceuticals, owns stock in Biohaven Ltd, was an employee of Pfizer, has received research payments from Pfizer, and provides services to Collima LLC which has had consulting agreements with Pfizer, Actio Biosciences, Inc., Aptose Biosciences Inc., Biohaven Pharmaceuticals, Inc., Manistee Therapeutics, and Vida Ventures Management Co., L.L.C. In addition, Dr Robert Croop reports a patent regarding CGRP antagonists, originally assigned to Biohaven Pharmaceuticals and now owned by Pfizer Inc. Alexandra Thiry is employed by Pfizer and owns stock/stock options in Biohaven Pharmaceuticals and Pfizer. Beth A Morris is employed by and owns stock/stock options in Biohaven Pharmaceuticals. The authors report no other conflicts of interest in this work.
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