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Rimegepant for Cluster Headache

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic Rochester, Rochester, MNCluster HeadacheRimegepant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if rimegepant can prevent cluster headaches.

Eligible Conditions
  • Cluster Headache

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Rimegepant
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rimegepant 75 mg ODT

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline, week of treatment (days 1-8)

Day 1
Change in weekly frequency of cluster headache attacks
Day 1
Change in daily frequency of cluster headache attacks
Change in daily headache severity

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
High Dose Psilocybin
2
Rimegepant
2
rimegepant 75 mg ODT

Trial Design

2 Treatment Groups

Chronic Cluster Headache Subjects
1 of 2
Cluster Headache Subjects
1 of 2

Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: Rimegepant · No Placebo Group · Phase 2

Chronic Cluster Headache Subjects
Drug
Experimental Group · 1 Intervention: Rimegepant · Intervention Types: Drug
Cluster Headache Subjects
Drug
Experimental Group · 1 Intervention: Rimegepant · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimegepant
2011
Completed Phase 3
~12080

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week of treatment (days 1-8)

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,959 Previous Clinical Trials
3,449,456 Total Patients Enrolled
Carrie Robertson, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with recurrent cluster headaches according to the International Classification of Headache Disorders-3.
You have headaches that happen between every other day and up to 8 times a day.
You experience severe headaches in one side of your head, which last 15-180 minutes when untreated.
You have a headache on one side of your head and other symptoms such as redness or tearing in the same eye, stuffy or runny nose, swollen eyelid, sweating on the same side of your face, small pupil or droopy eyelid, and feeling restless or agitated.
Your headaches are not caused by another medical condition.
You can tell the difference between cluster headaches and other types of headaches, like migraines.
If you take medicine to prevent headaches, you can still participate in the study as long as you have been taking the same dose for at least 2 months (or 6 months if you receive onabotulinumtoxinA injections) and do not plan on changing the dose during the study. However, if you take verapamil, you cannot participate.
You must have a history of cluster headaches happening between every other day to eight times a day, with at least four attacks during the one-week period before the trial starts. If you have episodic cluster headaches, you must have had them for at least six weeks.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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