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 range18 Years
SexALL
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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 …
What they're measuring
1
Change in weekly frequency of cluster headache attacks