A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine
Abstract
Objective: To assess the safety, tolerability, and treatment effects of rimegepant 75 mg every other calendar day (EOD) for the preventive treatment of migraine in a 52-week, open-label extension (OLE) study.
Background: Rimegepant is an oral small molecule calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine and the preventive treatment of episodic migraine in adults. The efficacy and safety of rimegepant for preventive treatment of migraine was demonstrated in a 12-week, phase 2/3, randomized, double-blind (DB), placebo-controlled trial in which rimegepant treatment produced significant improvement in the number of monthly migraine days (MMDs) with a safety profile similar to placebo.
Methods: In the DB trial period, an initial 4-week observation period was followed by a randomized, DB, 12-week treatment period. This was an optional 52-week OLE following the initial DB study for adults who completed the DB period. Participants were instructed to take one tablet of rimegepant 75 mg EOD for 52 weeks. If participants required an acute treatment of migraine on a non-scheduled dosing day, they could take one tablet of rimegepant 75 mg on that day (as-needed dosing). Secondary endpoints evaluated the safety and tolerability of rimegepant, including the frequencies of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3× upper limit of normal (ULN) concurrent with total bilirubin (TBIL) > 2× ULN, hepatic-related…
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: 603 participants or records.
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