Cluster Headache Treatment With Rimegepant (NCT05264714) | Clinical Trial Compass
CompletedPhase 2
Cluster Headache Treatment With Rimegepant
United States20 participantsStarted 2022-09-07
Plain-language summary
The purpose of this research is to explore the efficacy of rimegepant as a preventative therapy for cluster headache.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Subjects are required to …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in weekly frequency of cluster headache attacks