Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations

Condition(s) studied

Investigational drug(s) / intervention(s)

Rimegepant: 75mg

Placebo: matching placebo

Study summary

This non-interventional study will evaluate the efficacy of rimegepant 75 mg compared with placebo for the acute treatment of moderate or severe migraine attacks using individual participant data (IPD) from six completed randomized, double-blind, placebo-controlled clinical trials. The analysis includes data from adult participants with migraine with or without aura enrolled across studies conducted in the United States, China, South Korea, Japan, and multiple European and other international locations.

Although the efficacy of rimegepant has been established in individual trials and previous pooled analyses, conventional meta-analyses provide average treatment effects based on the mix of participants enrolled in the included studies and may not reflect outcomes expected in specific patient populations. The primary objective is to estimate the average treatment effects of rimegepant 75 mg relative to placebo for moderate or severe migraine attacks with respect to pain and symptom relief in prespecified target populations, including regional populations from Europe, the United States, China, South Korea, and Japan. A secondary objective is to evaluate treatment effects within clinically relevant subgroups defined by demographic and clinical characteristics.

Because this study uses existing data from completed clinical trials, no new participant recruitment, treatment assignment, or data collection will be conducted. The findings will contribute to the evidence base for rimegepant in the acute treatment of migraine.

Eligibility

Primary outcome measure(s)

• Pain Freedom at 2 Hours Postdose — 2 hours after administration of study treatment
  Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants who achieve pain freedom 2 hours after treatment of a moderate or severe migraine attack.
• Freedom From the Most Bothersome Symptom at 2 Hours Postdose — 2 hours after administration of study treatment
  Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants who are free from their prespecified most bothersome migraine-associated symptom 2 hours after treatment.
• Pain Relief at 2 Hours Postdose — 2 hours after administration of study treatment
  Average treatment effect of rimegepant 75 mg relative to placebo on the proportion of participants achieving pain relief 2 hours after treatment of a moderate or severe migraine attack.

Trial sites (1)

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