Rimegepant Shows Efficacy for Short-Term Prevention of Fasting-Related Headache

Once-daily rimegepant is well-tolerated and a potential option for short-term prevention of fasting-related headache (FRH), according to study results presented at the 2025 American Headache Society (AHS) Annual Scientific Meeting, held from June 19-22, in Minneapolis, Minnesota, and virtually.

Fasting is a well-known trigger for headaches, particularly in individuals with a primary headache disorder. The practice of fasting for religious, lifestyle, or medical reasons has increased in recent years, and the overall global burden of FRH has seen a similar increase.

Researchers conducted a single-center, 2-arm, randomized, staggered-start, open-label clinical trial to determine whether the calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant was a safe and effective preventive treatment for FRH in adults aged 18 to 65 who fasted during Ramadan. Individuals who had been diagnosed with FRH/migraine before the age 50 were included in the study and were randomly assigned to receive rimegepant 75 mg orally disintegrating tablet (ODT) from weeks 1 through 4 of the fast (Arm 1) or from weeks 2 through 4 of the fast (Arm 2).

The primary outcome was week 1 headache days, and the secondary outcomes included patient satisfaction and the proportion of participants with moderate-to-severe headache. The researchers also conducted a post hoc analysis of participants stratified by sex, baseline use of preventive medications, and migraine frequency.

A total of 104 patients were included in the study (mean age, 38.4; women, 78.1%), with 52 participants in each Arm. Mean Migraine Disability Assessment (MIDAS) score was 28.7, indicating severe disability.

A smaller proportion of headache days (least-squares mean, 1.74 vs 2.92; P =.005) and patients with moderate-to-severe headache (37% vs 69%) was observed during week 1 in Arm 1 vs Arm 2.

Overall, 82% of patients reported that they were satisfied, very satisfied, or extremely satisfied with the treatment; no treatment-related severe adverse events or discontinuations occurred.

In Arm 1, in the post hoc analysis, researchers found 35 participants used preventive medications at baseline, 39 had episodic migraine, and 44 were women. In Arm 2, a total of 15 participants used baseline preventive medications, 42 had episodic migraine, and 37 were women.

Week 1 headache days were significantly fewer in Arm 1 vs Arm 2 among those who used baseline preventives (mean, 2.00 vs 3.68 days; P =.015) and among those who did not (mean, 1.25 vs 3.07 days; P =.006). Similar results were observed for week 1 headache days in Arm 1 vs Arm 2 for participants with episodic migraine (mean, 1.55 vs 2.75 days; P =.007) and in those of female sex (mean, 1.76 vs 3.07 days; P =.006).

“Once-daily rimegepant 75 mg ODT may be effective and well-tolerated in short-term prevention of fasting-related headache,” the researchers concluded.

This study was supported by Pfizer. Please see the original reference for a full list of disclosures.