Improvements in Patient-Reported Outcome Measures Through 64 Weeks' Rimegepant Treatment for Migraine: Analysis of a Randomized Controlled Trial with Open-Label Extension
Abstract
Purpose: The current exploratory analysis of a Phase 2/3 randomized controlled trial focusses on patient-reported outcome measures from a 64-week study evaluating rimegepant for the preventive treatment of migraine in the USA.
Methods: Participants with migraine were randomly assigned to rimegepant 75 mg or placebo every other day during a 12-week double-blind treatment (DBT) phase. During a 52-week open-label extension (OLE) phase all participants took rimegepant 75 mg every other day and additionally on nonscheduled dosing days if needed. Migraine-Specific Quality of Life Questionnaire (MSQ) v.2.1 (including Role Function Restrictive [RFR] domain) and Migraine Disability Assessment Scale (MIDAS) were assessed throughout.
Results: 741 participants (mean [standard deviation] age 41.2 [13.06] years, 82.7% female) were treated with ≥1 dose of study drug in the DBT phase, and 603 participants were treated with rimegepant in the OLE phase. At Week 12 (end of DBT phase), for the rimegepant and placebo groups, respectively, mean (95% CI) improvements from baseline in MSQ RFR score were 18.6 (16.24, 20.94) and 15.0 (12.60, 17.37), and improvements in MIDAS Total score were -13.0 (-16.57, -9.52) and -12.0 (-15.52, -8.54). At Week 64 (end of OLE phase, all participants taking open-label rimegepant), for participants originally assigned DBT rimegepant and DBT placebo, respectively, mean (95% CI) improvements from baseline in MSQ RFR score were 32.6 (29.68, 35.42) and 33.2 (30.03,…
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: 741 participants or records.
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