NCT05264714

Cluster Headache Treatment With Rimegepant

Cluster Headache Treatment With Rimegepant-Open Label Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to explore the efficacy of rimegepant as a preventative therapy for cluster headache.

Detailed description

This is a prospective, open-label pilot study to investigate the use of rimegepant for the treatment of cluster headache. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, patients with cluster headache will start immediately keeping track of their headaches for a one-week baseline. In contrast, patients with episodic cluster headache will be asked to contact the study coordinator at the onset of their next cluster cycle, at which point they will repeat the screening and then start their one-week baseline headache diary. After establishing the baseline headache frequency, severity, and abortive medicine use, patients will be asked to start their first dose of study drug with their next moderate to severe cluster headache. They will rate their pain for this headache on a 5 point severity scale ("no headache," "mild," "moderate," "severe" or "very severe" and rate the pain on a scale of 0 to 10 ("0" is no pain and "10" is most severe pain imaginable) at the time of taking rimegepant and rate the pain again at 15, 30, 45, and 60 minutes after taking the drug. 60 or more minutes after taking the rimegepant, they are allowed to use their usual standard of care for the acute/abortive treatment of acute cluster attacks. After this first dose, they will then take rimegepant on an every other day schedule for a total of 4 doses over 8 days. A final visit for evaluation and collection of headache diaries will be conducted at the end of the study.

Conditions

• Cluster Headache

Interventions

Type	Name	Description
DRUG	Rimegepant	150 mg oral disintegrating tablet every other day for one week

Timeline

• Start date: 2022-09-07
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-03-03
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study