Prospective Open-label Pilot Study of Rimegepant as a Treatment for Cluster Headache
Carrie Robertson1, Jennifer Stern1, Chia-Chun Chiang1, Mark Whealy1, Krista Burke1, Narayan Kissoon1, Michael Cutrer1
1Neurology, Mayo Clinic
Objective:
Open-label pilot study to explore the efficacy and safety of high-dose rimegepant for the treatment of cluster headache.
Background:
Calcitonin gene-related peptide (CGRP) has been shown to be involved in the pathophysiology of cluster headache. Oral CGRP receptor antagonists have not been studied for cluster headache.
Design/Methods:
We enrolled 20 patients meeting ICHD-3 criteria for episodic or chronic cluster headache (ECH or CCH). CCH patients started immediately; ECH patients returned at the next cluster-cycle onset for rescreening.
After baseline monitoring for 7 days, subjects took rimegepant 150 mg at onset of severe headache, monitoring headache severity every 15 minutes. After one hour, they could treat with their preferred abortive. After the first dose, subjects would take the medication every other morning for 8 days (4 doses total of 150 mg each), while documenting headache frequency, severity, and abortive use.
Primary endpoint was change from baseline to treatment of mean weekly frequency of cluster headache attacks.
Results:
13 subjects (3 CCH/10 ECH) tried rimegepant; 11 provided complete treatment data. 5 subjects were “very satisfied” with rimegepant, 3 “somewhat satisfied,” 1 “neither satisfied nor dissatisfied,” 1 “somewhat dissatisfied,” and 3 “very dissatisfied.” 9/13 subjects reported wanting to use rimegepant again in the future. For 11 with complete data, mean change in headache frequency was -4.0 headaches/week comparing treatment to baseline, with reduced average headache duration of -14.9 minutes. Three subjects had a >50% reduction in their attack frequency and one had a 40% reduction in attack frequency. 30 minutes after the first dose, 6/13 subjects reported improved severity by ≥ 1 on 5-point Likert scale. Two patients were headache-free at 15 minutes. Rimegepant was tolerated well, other than one patient with asymptomatic LFT’s >3 x upper limit of normal.
Conclusions:
Rimegepant may be helpful in a subset of cluster headache patients. Larger studies are needed.
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.