Abstract Details

Title Prospective Open-label Pilot Study of Rimegepant as a Treatment for Cluster Headache

Topic Headache

Presentation(s) P6 - Poster Session 6 (5:00 PM-6:00 PM)

Poster/Presentation
Number 15-014

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.

Authors/Disclosures
Carrie E. Robertson, MD, FAAN (Mayo Clinic) PRESENTER	Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Linpharma. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Satsuma. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Apeya. Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for UpToDate. The institution of Dr. Robertson has received research support from Biohaven/Pfizer. Dr. Robertson has received publishing royalties from a publication relating to health care. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Research consultant with University of Minnesota.
Jennifer Stern, MD (Mayo Clinic)	An immediate family member of Dr. Stern has stock in Emmyon, Inc.. The institution of an immediate family member of Dr. Stern has received research support from NIH.
Chia-Chun Chiang, MD (Mayo Clinic)	Dr. Chiang has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Chiang has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aruene Corporation . Dr. Chiang has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Chiang has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Chiang has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. The institution of Dr. Chiang has received research support from American Heart Association. The institution of Dr. Chiang has received research support from Lundbeck. The institution of Dr. Chiang has received research support from Pfizer.
Mark A. Whealy, MD (Mayo Clinic Department of Neurology)	Dr. Whealy has received publishing royalties from a publication relating to health care.
Krista Burke, NP (Mayo Clinic)	Mrs. Burke has nothing to disclose.
Narayan R. Kissoon, MD	Dr. Kissoon has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vertex Pharmaceuticals. The institution of Dr. Kissoon has received research support from Nevro Corporation. The institution of Dr. Kissoon has received research support from Novo Nordisc Foundation. The institution of Dr. Kissoon has received research support from Shiratronics. Dr. Kissoon has received publishing royalties from a publication relating to health care.
F. M. Cutrer, MD (Mayo Clinic)	Dr. Cutrer has received publishing royalties from a publication relating to health care.

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