A randomized open-label study to evaluate the effectiveness and safety of once-daily rimegepant 75 mg orally disintegrating tablet for the short-term preventive treatment of fasting-triggered headache in individuals with migraine
Abstract
AimTo evaluate rimegepant, a calcitonin gene-related peptide receptor antagonist, for short-term prevention of fasting-triggered headache during Ramadan.MethodsParticipants, aged 18-65 years and diagnosed with migraine or headache attributed to fasting, were randomized to open-label once-daily (QD) rimegepant 75 mg orally disintegrating tablet (ODT) from weeks 1-4 of the fast (Immediate Start arm; n = 52) or weeks 2-4 of the fast (Staggered Start arm; n = 53). The primary endpoint was the difference in number of headache days of any intensity between the Immediate Start and Staggered Start arms during week 1. Other endpoints included headache days during weeks 2-4, moderate-to-severe headache days during weeks 1-4, headache duration (any intensity and moderate-to-severe) during weeks 1-4, rescue medication use during weeks 1-4 and treatment satisfaction. Treatment comparisons utilized nominal p values. Safety endpoints included adverse events (AEs), serious AEs and discontinuations due to AEs.ResultsAll participants (n = 105) had a diagnosis of migraine and a history of headaches during fasting. The number of headache days of any intensity during week 1 (primary endpoint) was lower in the Immediate Start arm vs. the Staggered Start arm (LS mean (95% confidence interval) = 1.74 (1.16-2.31) days vs. 2.92 (2.34-3.49) days; p = 0.005). There were no significant differences between arms during weeks 2-4. Total duration of headaches of any intensity was shorter in the Immediate…
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: 105 participants or records.
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