Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache: A Prospective, Open-Label, Single-Arm, Interventional Pilot Study
The University of Texas Health Science Center, Houston
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
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugZavegepant 20 mg
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.
Location
- The University of Texas Health Science Center at HoustonHouston, Texas