Study designs
For the acute indication, Nurtec ODT was evaluated in a multi‑center, double‑blind, randomized, placebo‑controlled study of 1351 patients (Nurtec ODT 75 mg, n=669; placebo, n=682), with co‑primary endpoints at 2 h for Nurtec ODT vs placebo: pain freedom (21% vs 11%, P<.001) and freedom from most bothersome symptoms (MBS; predefined as photophobia, phonophobia, or nausea; 35% vs 27%; P=.001).1
For the preventive indication, rimegepant 75 mg was evaluated in a multi‑center, double‑blind, randomized, placebo‑controlled study of 695 patients (rimegepant 75 mg, n=348; placebo, n=347) with the primary endpoint being change from baseline in the mean number of monthly migraine days during weeks 9‑12 (-4.3 vs -3.5, P=.01).1
A long-term open label safety study with 1800 patients evaluated rimegepant 75 mg dosed as needed for 52 weeks (N=1514) and dosed every other day plus as needed for 12 weeks (N=286).1,8