The purpose of this study is to evaluate the safety and efficacy of intranasally administered civamide nasal solution in the prevention of cluster headaches during an episodic cluster headache period.
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:
* Written IRB-approved informed consent has been obtained and signed, within 12 months of entering into the Baseline Period (Day -3).
* Male or female 18 years or older.
* Subject has ≥2 year history of episodic cluster headache with at least 2 previous episodic cluster headache periods.
* Cluster Headaches must meet the following International Headache Society Diagnostic Criteria :
* Severe, unilateral, orbital, superorbital and/or temporal pain lasting 15 to 180 minutes untreated.
* Headache is associated with at least one of the following which have to be present on the side of the pain:
* Conjunctival injection
* Lacrimation
* Nasal Congestion
* Rhinorrhea
* Forehead and facial sweating
* Miosis
* Ptosis
* Eyelid edema or
* A sense of restlessness or agitation
* The current episodic cluster headache period is expected to last at least 5 weeks but no more than 24 weeks from the time of entry into the Baseline Period (Day -3), based on the average duration of the subject's usual episodic cluster headache period.
* At least one cluster headache (but no more than 8) daily on each of the three days of the Baseline Period (Days -3, -2, -1) immediately preceding Study Day 1.
* The subject is in generally good health, other than history of episodic cluster headache.
* The subject agrees not to begin any new concurrent medications or restricted medications during their participation in study.
* All females of childbear…
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
The Percent Change in the Number of Cluster Headaches per Week from Baseline to Weeks 1 through 3 of the Post-Treatment Observation Period for the Modified Intent-to-Treat Population
Timeframe: Weeks 1 - 3 of the Post-Treatment Observation Period