Evidence map›Paper›PMID 38627638›Full record

Trial reportThe journal of headache and pain2024

Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial.

Shengyuan Yu, Aihong Guo, Zhen Wang, Jianguang Liu, Ge Tan, Qian Yang, Mingjie Zhang, Hasiyeti Yibulaiyin, Huisheng Chen, Yongbo Zhang and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in The journal of headache and pain, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04574362 (BHV3000-310), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
10.0field-weighted citation impact, top 1% of its field
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.

NCT04574362 phase3completednot on this map

BHV3000-310: Phase 3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine

TypeinterventionalSponsorPfizerRan2020 to 2021Enrolled1,648ConditionsAcute MigraineArmsRimegepant, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Observational
  5. Article
  6. Article
  7. 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

15 authors at 9 institutions in 2 countries.

Shengyuan YuChinese PLA General Hospital, Beijing, China.
Aihong GuoXianyang Hospital, Yan'an University, Xianyang, China.
Zhen WangChangsha Central Hospital, Changsha, China.
Jianguang LiuWuhan Third Hospital, Wuhan, China.
Ge TanThe First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Qian YangShaanxi Provincial Hospital, Xi'an, China.
Mingjie ZhangChinese PLA General Hospital, Beijing, China.
Hasiyeti YibulaiyinThe Second Affiliated Hospital of Xinjiang Medical University, Wulumuqi, Xinjiang Province, China.
Huisheng ChenGeneral Hospital of Northern Theater Command, District, Shenyang, Liaoning Province, China.
Yongbo ZhangBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Robert CroopBiohaven Pharmaceuticals, New Haven, CT, USA.
Yanhui SunPfizer (China) Research and Development Co., Ltd, Shanghai, China.
Yu LiuPfizer Inc, Beijing, China.
Qian ZhaoPfizer Inc, Chengdu, China.
Zhihong LuPfizer (China) Research and Development Co., Ltd, Shanghai, China. luzhihong57@outlook.com.
Pfizer (China) · CNChinese PLA General Hospital · CNBiohaven Pharmaceuticals (United States) · USCapital Medical University · CNChangsha Central Hospital · CNChongqing Medical University · CNGeneral Hospital of Shenyang Military Region · CNWuhan Third Hospital · CNXinjiang Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRimegepant orally disintegrating tablet (ODT), an oral small-molecule calcitonin gene-related peptide receptor antagonist, is indicated for acute and preventive treatment of migraine in the United States and other countries. Previously, a large clinical trial assessed the efficacy and safety of rimegepant ODT 75 mg for the acute treatment of migraine in adults living in China or South Korea. A post hoc subgroup analysis of this trial was performed to evaluate the efficacy and safety of rimegepant for acute treatment of migraine in adults living in China.

methodsEligible participants were ≥ 18 years of age and had a ≥ 1-year history of migraine, with 2 to 8 attacks of moderate or severe pain intensity per month and < 15 headache days per month during the 3 months before screening. Participants self-administered rimegepant ODT 75 mg or matching placebo to treat a single migraine attack of moderate or severe pain intensity. The co-primary endpoints were pain freedom and freedom from the most bothersome symptom (MBS) at 2 h post-dose. Key secondary endpoints included pain relief at 2 h post-dose, ability to function normally at 2 h post-dose, use of rescue medication within 24 h post-dose, and sustained pain freedom from 2 to 24 h and 2 to 48 h post-dose. All p values were nominal. Safety was assessed via treatment-emergent adverse events (TEAEs), electrocardiograms, vital signs, and routine laboratory tests.

resultsOverall, 1075 participants (rimegepant, n = 538; placebo, n = 537) were included in the subgroup analysis. Rimegepant was more effective than placebo for the co-primary endpoints of pain freedom (18.2% vs. 10.6%, p = 0.0004) and freedom from the MBS (48.0% vs. 31.8%, p <  0.0001), as well as all key secondary endpoints. The incidence of TEAEs was comparable between the rimegepant (15.2%) and placebo (16.4%) groups. No signal of drug-induced liver injury was observed, and no study drug-related serious TEAEs were reported in the rimegepant group.

conclusionsA single dose of rimegepant 75 mg rimegepant was effective for the acute treatment of migraine in adults living in China, with safety and tolerability similar to placebo.

trial registrationClinicaltrials.gov NCT04574362 Date registered: 2020-10-05.

Indexed as

Migraine DisordersPiperidinesPyridinesAdultChinaDouble-Blind MethodHumansPainTabletsTreatment OutcomePiperidinesPyridinesrimegepant sulfateTabletsAcute treatmentChinaClinical trialMigraineRimegepant

Identifiers

PMID38627638
PMCPMC11020209
OpenAlexW4394848066

What OpenQuestion holds

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LicenceCC BY
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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.