Zavegepant for Cluster Headache

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

MJ

Mark J Burish, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults who experience episodic cluster headaches. Participants should be generally healthy aside from their headache condition and meet specific criteria set by the study team.

Inclusion Criteria

My cluster headache attacks last at least 45 minutes without treatment.
I have had at least two previous headache episodes.
I have been diagnosed with episodic cluster headaches.
See 2 more

Exclusion Criteria

I have stage 4 kidney disease with very low kidney function.
I have used or cannot tolerate zavegepant for reasons other than cluster headaches.
Body mass index ≥ 35 kg/m2
See 26 more

What Are the Treatments Tested in This Trial?

Interventions

  • Zavegepant

Trial Overview

The study is testing a nasal spray called Zavegepant (20 mg) to see how well it relieves pain from cluster headaches within 30 minutes, compared to other timepoints after use.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ZavegepantExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Pfizer

Industry Sponsor

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Recruited
50,980,000+
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Vaccine Innovations
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Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

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Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University