Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache (NCT07714369) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache
United States40 participantsStarted 2026-10-01
Plain-language summary
The purpose of this study is to assess headache response rate for minimal pain at 30 minutes following zavegepant administration and to assess additional effectiveness and treatment failure endpoints at various timepoints after zavegepant administration
Who can participate
Age range
18 Years – 70 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:
* A diagnosis of episodic cluster headache according to the International Classification of Headache Disorders 3rd edition
* A history of at least 2 prior headache bouts
* Onset of cluster headache before age 50 years
* Cluster headache attacks last a minimum duration of 45 minutes (if untreated)
* Evidence of signed informed consent (ICF) as described in the protocol, indicating compliance with the requirements and restrictions listed in the ICF and this protocol
Exclusion Criteria:
General exclusions
* Pregnant or breastfeeding patients.
* Inability to follow training instructions for use of nasal device.
* Unable to speak or read English.
* Unable to access the internet (for the Questionnaires / Case Report Forms).
* Females of childbearing potential, without the ability to use 2 acceptable methods of contraception to avoid pregnancy for up to 48 hours after each study drug administration, followed by 1 acceptable method for 28 days after the last administration of study treatment.
* Body mass index ≥ 35 kg/m2
* Prisoners or subjects who are involuntarily incarcerated.
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
* Have participated in another clinical research study with biological investigational agents (or other relevant agents) in the last 90 days.
* Positive drug screen for drugs of abuse at the investigator's discretion (e.g., positive amphetamines may be allowed…
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
Percentage of participants who achieve minimal pain at 30 minutes following their first administration of zavegepant 20mg.
Timeframe: end of study (up to 70 days from baseline)
Trial details
NCT IDNCT07714369
SponsorThe University of Texas Health Science Center, Houston