Rimegepant Effective, Safe for Migraine

Robert Croop, M.D.

Findings of a recent study suggest when taken every other day, rimegepant is effective for preventive treatment of migraine.

Robert Croop, M.D., and colleagues aimed to compare the efficacy of rimegepant with placebo for preventive treatment of the condition. The team conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of rimegepant at 92 study centers across the U.S. The study consisted of three phases: a screening phase including a four-week observation period, a 12-week double-blind treatment phase, and a 52-week open-label extension phase.

To be eligible, participants had to be at least 18 years old with at least a one-year history of migraine with aura, migraine without aura, or chronic migraine, and an initial presentation of migraine before 50 years old. Additionally, participants had to have at least four, and not more than 18, migraine attacks of moderate or severe intensity per month over the three-month period before the screening visit and at least six migraine days during the four-week observation period.

During the observation period, participants used an electronic diary to document the occurrence and severity of migraine attacks and a paper diary to record use of all migraine treatments. At the baseline visit, participants who met all inclusion criteria were given 30 tablets of either rimegepant 75 mg or matching placebo. Participants were instructed to take one tablet every other calendar day. The participants continued tracking their migraine attacks.

Following the baseline visit, participants returned to the study site at weeks two, four, eight, and 12 for review by study personnel of the diaries, to assess study medication compliance, and monitor the tolerability and safety of the drug.

The primary endpoint was change form the four-week observation period in the mean number of migraine days per month in the last four weeks of the double-blind treatment phase. Additional endpoints were achievement of at least a 50% reduction from the four-week observation period in the mean number of moderate or severe migraine days per month in the last four weeks of the double-blind treatment phase. Other endpoints included the change from the four-week observation period in the mean number of migraine days per month across the double-blind treatment phase and change from the four-week observation period in the mean number of migraine days per month in the first four weeks of the double-blind treatment phase.

Overall, 747 participants were randomly assigned to receive rimegepant (373 patients) or placebo (374 patients). Of the participants, 695 were included in the analysis for efficacy, of whom 348 were assigned rimegepant and 347 received placebo. The drug was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9-12. The change in the number of migraine days was -4.3 days (95% CI, -4.8 to -3.9) with rimegepant and -3.5 days (95% CI, -4 to -3) with placebo.

In the safety analysis of 741 participants, 36% of the 370 patients who received rimegepant reported an adverse event compared with 36% of 371 patients who received placebo.

The findings demonstrated the tolerability and efficacy of rimegepant for migraine.

The study, “Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial,” was published online in The Lancet.