Cluster Headache Treatment With Rimegepant

NCT05264714 | Completed Phase 2 FDA Drug

• 1 other identifier: 21-003394
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (1)

• Change in weekly frequency of cluster headache attacks

  Total number of cluster headache attacks experienced in one week

  Baseline, week of treatment (days 1-7)

Secondary Outcomes (2)

• Change in daily headache severity

  Baseline, week of treatment (days 1-8)

• Change in daily frequency of cluster headache attacks

  Baseline, week of treatment (days 1-8)

Study Arms (1)

Cluster Headache Subjects

EXPERIMENTAL

Subjects with cluster headaches will track their headaches for a one-week baseline headache diary. After establishing the baseline headache frequency, severity, and abortive medicine use, subjects will be asked to start their first dose of rimegepant with their next moderate to severe cluster headache.

Drug: Rimegepant

Interventions

Rimegepant DRUG

150 mg oral disintegrating tablet every other day for one week

Also known as: Nurtec ODT

Cluster Headache Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a diagnosis of recurrent cluster headaches, as described by ICHD-3 (International Classification of Headache Disorders-3):
• Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes, when untreated.
• Headache is accompanied by at least one of the following:
• Ipsilateral conjunctival injection and/or lacrimation;
• Ipsilateral nasal congestion and/or rhinorrhea;
• Ipsilateral eyelid edema;
• Ipsilateral forehead and facial sweating;
• Ipsilateral miosis and/or ptosis;
• A sense of restlessness or agitation.
• Headache attacks occur at a frequency between every other day and 8 per day.
• Headaches are not attributed to another disorder.
• Subjects able to distinguish cluster headache attacks from other headache disorders, such as migraine.
• Subjects on prophylactic headache medicines other than verapamil will be permitted to remain on these with possible headache-prophylactic effects if the dose is stable for at least 2 months (onabotulinumtoxinA injections stable for 6 months) prior to the screening visit and the dose is not expected to change during the course of the study.
• Prior MR (magnetic resonance) imaging of head (CT if MRI contraindicated) performed after the onset of headaches.
• Subjects agree to refrain from starting a new prophylactic cluster headache medicine, including steroids and nerve blocks, during the course of the study.

You may not qualify if:

• Subjects with a history of an adverse reaction to CGRP (calcitonin gene-related peptide) antibodies or another CGRP antagonist (gepant).
• Subjects with episodic cluster who are felt to be toward the end of their cluster cycle (estimated to be within the last 4 weeks).
• Pregnancy (negative serum pregnancy testing at enrollment and use of contraception considered to be effective).
• Subjects with a history of uncontrolled, unstable, or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), stroke, or transient ischemic attack (TIA) in the 6 months prior to screening.
• Subjects with other pain syndromes, psychiatric conditions, dementia or significant neurological disorders that, in the investigator's opinion might interfere with study assessments.
• Use of peripheral nerve blocks (e.g., occipital, supraorbital, auriculotemporal, and/or sphenopalatine ganglion nerve blocks) one month prior to enrollment.
• Use of opioids or barbiturates more than 5 days per month.
• Use of other small molecule CGRP antagonist (gepant) 1 month prior to enrollment or during duration of study
• Use of verapamil during the study
• Use of CGRP monoclonal antibodies 3 months prior to enrollment or during duration of study.
• Subjects with a secondary cluster headache related to an underlying structural etiology identified by imaging (CT or MRI).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cluster Headache

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Carrie Robertson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: September 7, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)