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Open Access 01-12-2024 | Migraine | Research

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

Authors: Shengyuan Yu, Aihong Guo, Zhen Wang, Jianguang Liu, Ge Tan, Qian Yang, Mingjie Zhang, Hasiyeti Yibulaiyin, Huisheng Chen, Yongbo Zhang, Robert Croop, Yanhui Sun, Yu Liu, Qian Zhao, Zhihong Lu

Published in: The Journal of Headache and Pain | Issue 1/2024

Abstract

Background

Rimegepant 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.

Methods

Eligible 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.

Results

Overall, 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.

Conclusions

A 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 registration

Clinicaltrials.gov NCT04574362 Date registered: 2020-10-05.

Graphical Abstract

Available only for authorised users

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Title: 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
Authors: Shengyuan Yu
Aihong Guo
Zhen Wang
Jianguang Liu
Ge Tan
Qian Yang
Mingjie Zhang
Hasiyeti Yibulaiyin
Huisheng Chen
Yongbo Zhang
Robert Croop
Yanhui Sun
Yu Liu
Qian Zhao
Zhihong Lu
Publication date: 01-12-2024
Publisher: Springer Milan
Keywords: Migraine
Medication Overuse Headache
Published in: The Journal of Headache and Pain / Issue 1/2024
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI: https://doi.org/10.1186/s10194-024-01731-4

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

Trial registration

Graphical Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

Graphical Abstract

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