Evidence map›Paper›PMID 40586377›Full record

Trial reportHeadache

Efficacy and safety of rimegepant for the acute treatment of migraine in Japan: A dose-ranging, double-blind, randomized controlled trial.

Koichi Ikeda, Yasuhiko Matsumori, Masako Kudo, Tomofumi Ishikawa, Yuko Hoshino, Hiroki Yoshimatsu, Alexandra Thiry, Akio Arakawa, Robert Croop, Terence Fullerton and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Headache. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05399459 (Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05399459 phase3completednot on this map

Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects

TypeinterventionalSponsorPfizerRan2022 to 2024Enrolled897ConditionsMigraineArmsRimegepant 25 MG, Rimegepant 75 MG, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Observational
  8. Review
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Koichi IkedaIkeda Neurosurgical Clinic, Fukuoka, Japan.
Yasuhiko MatsumoriSendai Headache and Neurology Clinic, Miyagi, Japan.
Masako KudoDepartment of Neurology and Gerontology, Iwate Medical University, Iwate, Japan.
Tomofumi IshikawaPfizer R&D Japan, Tokyo, Japan.ORCID 0000-0002-0901-368X
Yuko HoshinoPfizer R&D Japan, Tokyo, Japan.
Hiroki YoshimatsuPfizer R&D Japan, Tokyo, Japan.
Alexandra ThiryPfizer, Groton, Connecticut, USA.
Akio ArakawaPfizer R&D Japan, Tokyo, Japan.
Robert CroopBiohaven Pharmaceuticals, New Haven, Connecticut, USA.
Terence FullertonPfizer, Groton, Connecticut, USA.
Fumihiko SakaiSaitama International Headache Center, Saitama Neuropsychiatric Institute, Saitama, Japan.
Takao TakeshimaHeadache Center, Department of Neurology, Tominaga Hospital, Osaka, Japan.

Funding

Biohaven PharmaceuticalsPfizer
6 · The paper itself

Abstract

objectiveThe objectives of this study were to compare the efficacy, including dose response, and safety of rimegepant, an orally administered small-molecule calcitonin gene-related peptide receptor antagonist, with placebo for the acute treatment of migraine in Japan.

backgroundThere is a substantial unmet need for the acute treatment of migraine in Japan due to undesirable attributes of existing acute treatments.

methodsIn this Phase 2/3, double-blind, randomized trial, adults with a ≥1-year history of migraine were recruited to 50 study centers in Japan. Participants were randomly assigned to receive rimegepant 25 mg, rimegepant 75 mg, or placebo and instructed to treat a single migraine attack of moderate or severe pain intensity. The randomization was stratified by preventive migraine medication use (yes or no). The primary endpoint was the proportion of participants with pain freedom at 2 h post-dose. Formal hypothesis testing was conducted for rimegepant 75 mg versus placebo. Safety was assessed based on adverse events (AEs).

resultsThe study was conducted from August 9, 2022, through January 19, 2024. A total of 706 treated participants were evaluable for efficacy (rimegepant 25 mg, n = 238; rimegepant 75 mg, n = 238; placebo, n = 230) and safety (rimegepant 25 mg, n = 239; rimegepant 75 mg, n = 238; placebo, n = 229). Response rates for pain freedom at 2 h post-dose were 21.0% (rimegepant 25 mg), 32.4% (rimegepant 75 mg), and 13.0% (placebo): percentage difference rimegepant 75 mg versus placebo was 19.4% (95% confidence interval 12.0-26.8%, p < 0.001). On-treatment AEs were reported by 7.1% (rimegepant 25 mg), 9.2% (rimegepant 75 mg), and 6.6% (placebo) of treated participants; all were mild or moderate in intensity and most were not considered related to the study drug.

conclusionRimegepant 75 mg demonstrated efficacy superior to placebo for the acute treatment of migraine, with a favorable safety profile, in participants in Japan. A dose-response relationship was observed for rimegepant (NCT05399459). PLAIN LANGUAGE SUMMARY: This randomized trial was designed to test the effectiveness and safety of rimegepant for the acute treatment of migraine among adults in Japan. Results indicated that rimegepant was more effective than placebo, and the 75 mg dose was observed to be more effective than the 25 mg dose. These results are similar to previous findings from clinical studies in other countries, and suggest that rimegepant can help patients with migraine in Japan.

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersOutcome Assessment, Health CarePiperidinesPyridinesAdultAgedDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansJapanMaleMiddle AgedTreatment OutcomeYoung AdultCalcitonin Gene-Related Peptide Receptor AntagonistsPiperidinesPyridinesrimegepant sulfateacute treatmentcalcitonin gene‐related peptide receptor antagonistheadachemigrainepainrimegepant

Identifiers

PMID40586377
PMCPMC12638520

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.