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Calcitonin Gene-Related Peptide (CGRP) Antagonist

Rimegepant for Cluster Headache

Phase 2
Recruiting
Led By Carrie Robertson, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week of treatment (days 1-8)
Awards & highlights

Study Summary

This trial is testing if rimegepant can prevent cluster headaches.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly stated here, common side effects from similar treatments include nausea, dizziness, dry mouth, sleepiness and potential allergic reactions. As this is an investigational study, there may be unknown risks that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
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You have a medical diagnosis of severe, recurring headaches that last between 15 and 180 minutes.
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Your headache is accompanied by specific symptoms like red eyes, runny nose, or sweating on one side of your face.
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You have headaches happening every other day up to 8 times a day.
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Your headaches are not caused by another health problem.
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You can tell the difference between cluster headaches and other types of headaches like migraines.
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If you take medicine to prevent headaches, you can still participate if the dose has been the same for at least 2 months (or 6 months for onabotulinumtoxinA injections) and it won't change during the study.
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You had a brain MRI or CT scan after you started having headaches.
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You must have cluster headaches happening between every other day and eight times a day, with at least four attacks in the past week. If you have episodic cluster headaches, your headache periods must have lasted at least 6 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week of treatment (days 1-8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week of treatment (days 1-8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in weekly frequency of cluster headache attacks
Secondary outcome measures
Change in daily frequency of cluster headache attacks
Change in daily headache severity

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimegepant
2021
Completed Phase 4
~12670

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,475 Total Patients Enrolled
Carrie Robertson, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Rimegepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05264714 β€” Phase 2
Cluster Headache Research Study Groups: Cluster Headache Subjects
Cluster Headache Clinical Trial 2023: Rimegepant Highlights & Side Effects. Trial Name: NCT05264714 β€” Phase 2
Rimegepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05264714 β€” Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research participants are involved in this endeavor?

"Indeed, the information located on clinicaltrials.gov attests to this trial's ongoing recruitment process; it was first posted September 7th 2022 and its most recent update occurred a day prior. The study calls for 10 participants from one medical centre."

Answered by AI

Has Rimegepant been given the green light by the FDA?

"While there is evidence that rimegepant possesses a certain degree of safety, as judged by the Phase 2 clinical trial standards, it only achieved a score of 2. This indicates that further studies are necessary to demonstrate its efficacy."

Answered by AI

Are there any patient slots available for this experimental trial currently?

"Yes, current information on clinicaltrials.gov points to the fact that this trial is presently enrolling individuals. It was initially posted in September 7th 2022 and updated most recently on July 6th 2022. The research team seeks 10 participants at a single site."

Answered by AI

Who else is applying?

What site did they apply to?
Mayo Clinic Rochester
What portion of applicants met pre-screening criteria?
Met criteria
~3 spots leftby Dec 2024