Rimegepant is a CGRP receptor antagonist approved for acute treatment of migraine and prevention of episodic migraine in adults.

Patients (18–65 years) diagnosed with fasting-related headache/migraine prior to 50 years were eligible for the single-center, 2-arm, randomized, staggered-start, open-label study of once-daily rimegepant 75mg orally disintegrating tablet (ODT). Patients were randomized to rimegepant from Weeks 1–4 of the fast (Arm 1) or Weeks 2–4 of the fast (Arm 2). Primary endpoint was headache-days (HDs) during Week 1. Secondary endpoints included proportion with moderate-to-severe headache and patient satisfaction. Safety endpoints included discontinuation due to adverse events (AEs) and frequency of serious AEs (SAEs). Post hoc, patients were categorized by baseline use of preventive medications (yes/no), migraine frequency (chronic/episodic), and gender (male/female).

104 patients received rimegepant (n=52 in both arms). HDs during Week 1 were significantly fewer in Arm 1 than Arm 2 (least-squares mean: 1.74 vs 2.92; p=0.005). Proportion of patients with moderate-to-severe headache during Week 1 was smaller in Arm 1 than Arm 2 (37 vs 69%). Most patients (82%) were satisfied, very satisfied, or extremely satisfied with treatment. No discontinuations or treatment-related SAEs occurred. Arm 1 included 35 patients using preventive medications, 39 with episodic migraine, and 44 females, while corresponding numbers in Arm 2 were 15, 42, and 37. HDs during Week 1 were significantly fewer in Arm 1 than Arm 2 for patients using preventive medications (mean: 2.00 vs 3.68; p=0.015) or not (mean: 1.25 vs 2.59; p=0.022). HDs during Week 1 were significantly fewer in Arm 1 than Arm 2 for patients with episodic migraine (mean: 1.55 vs 2.75; p=0.007) and for females (mean: 1.76 vs 3.07; p=0.006).