Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache
Part of paid clinical trials in Houston, Texas.
- Sponsor
- The University of Texas Health Science Center, Houston
- Study ID
- NCT07714369
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Cluster Headache
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Zavegepant 20 mg — DRUGParticipants will administer zavegepant 10 mg twice in quick succession (once into the left nostril, once into the right nostril, for a total of 20mg) to treat up to 3 separate cluster headache attacks maintaining a minimum interval of 48 hours between administrations.
Study Details
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
Key Dates
- First listed
- Jul 20, 2026
- Start date
- Oct 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Apr 1, 2028
- Completion
- May 1, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Zavegepant
Primary Outcome Measure
Percentage of participants who achieve minimal pain at 30 minutes following their first administration of zavegepant 20mg. [ Time Frame: end of study (up to 70 days from baseline) ]
Central Contacts
- Mark J Burish, MD, PhD713-486-7771
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 |
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