Efficacy and safety of rimegepant for the acute treatment of migraine in Black or African American adults: A post hoc pooled subgroup analysis from three randomized, placebo-controlled clinical trials
Abstract
OBJECTIVE: This post hoc subgroup analysis was conducted using pooled data from three US-based clinical trials to compare efficacy and safety of rimegepant 75 mg versus placebo in acute migraine in adults who are Black or African American.
BACKGROUND: Migraine, characterized by recurring moderate-to-severe unilateral head pain, affects approximately 13% of the population and in the United States affects Black or African American and White populations at similar rates. Despite this, there is stark underrepresentation of Black or African American patients in clinical trials. Rimegepant, an oral small molecule calcitonin gene-related peptide receptor blocker or antagonist, is approved for acute migraine treatment in the United States; however, treatment has not previously been analyzed in Black or African American adults.
METHODS: Using pooled data from three US-based, double-blind, randomized, placebo-controlled, multicenter clinical trials (ClinicalTrials.gov, NCT03235479; NCT03237845; NCT03461757), efficacy analyses were conducted on a modified intent-to-treat population including all participants who received study medication, had a migraine attack of moderate or severe pain intensity at the time of dosing, and provided ≥1 efficacy datapoint after receiving study treatment. Trials were conducted July 2017 to January 2018 (NCT03235479, NCT03237845) or February 2018 to October 2018 (NCT03461757). The coprimary efficacy endpoints of each trial were freedom from pain (score 0 =…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 3,551 participants or records.
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