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Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache

NCT07714369 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-20

No results posted yet for this study

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

Conditions

  • Cluster Headache

Interventions

DRUG

Zavegepant 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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Mark J Burish, MD, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-04-01
Completion
2028-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07714369 on ClinicalTrials.gov