1. Patients with migraine treated with rimegepant during an acute event had resolution of pain and their most bothersome symptoms 2 hours after onset more frequently than patients treated with placebo.
2. Incidence of adverse events were similar for patients treated with either rimegepant or placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Migraine is a common and debilitating headache condition. Treatment with triptans for acute episodes are often either not effective or can be contraindicated in certain patients. Calcitonin gene–related peptide (CGRP) has been associated with migraine pathology, and prior studies have shown inhibition of CGRP can effectively treat migraine. This phase 3 randomized controlled trial compared the CGRP small molecule inhibitor rimegepant to placebo for acute migraine treatment. The primary outcome of pain 2 hours after treatment administration showed more patients were pain free and free of their most bothersome symptoms when treated with rimegepant compared to placebo. Nausea and urinary tract infections were the most common adverse events and reported at similar rates in the treatment and placebo groups.
This large randomized study provides clinically meaningful, patient-centric data to suggest rimegepant as an efficacious treatment of acute migraine. The study is significantly limited by its lack of comparison to a triptan, or other active drug treatment.