Rimegepant for Cluster Headache

Recruiting in Palo Alto (17 mi)

Overseen byCarrie Robertson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing rimegepant, a medication that may help prevent cluster headaches. It targets patients who suffer from these severe headaches, especially those who don't respond well to other treatments. Rimegepant works by blocking pain signals in the brain. It was initially approved for treating migraines and is now being studied for preventing them.

Eligibility Criteria

This trial is for individuals with recurrent cluster headaches not caused by another disorder. Participants must have had MR imaging to rule out other causes, experience specific symptoms like severe unilateral pain and restlessness during attacks, and have a certain frequency of headaches. They can't join if they're near the end of a cluster cycle, have recent serious heart issues or are pregnant. Those on stable doses of certain headache medicines may be eligible.

Inclusion Criteria

This criterion requires that a headache is accompanied by at least one of the following:

You have been diagnosed with recurrent cluster headaches according to specific guidelines.

Subjects agree to refrain from starting a new prophylactic cluster headache medicine, including steroids and nerve blocks, during the course of the study.

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Exclusion Criteria

You have been experiencing cluster headaches that are likely ending within the last 4 weeks.

You have had heart problems like a heart attack, heart surgery, or stroke in the past 6 months.

Pregnancy (negative serum pregnancy testing at enrollment and use of contraception considered to be effective).

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Participant Groups

The study tests rimegepant's effectiveness as a preventive treatment for cluster headaches. It aims to see if taking rimegepant reduces the frequency or severity of headache episodes in participants who meet strict criteria based on their headache patterns and associated symptoms.

1Treatment groups

Experimental Treatment

Group I: Cluster Headache SubjectsExperimental Treatment1 Intervention

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.

Rimegepant is already approved in United States, European Union, Canada, United Kingdom for the following indications:

🇺🇸 Approved in United States as Nurtec ODT for: