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 — DRUG
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Mark J Burish, MD,PhD
(713) 704-3127

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