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?

This trial tests zavegepant, a new treatment for people with cluster headaches. The goal is to assess its ability to reduce pain within 30 minutes and to monitor its effectiveness over time. This trial suits individuals who have experienced cluster headaches for a while, with untreated attacks lasting at least 45 minutes. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that zavegepant is likely to be safe for humans?

Research has shown that zavegepant, a treatment under study for cluster headaches, is safe for treating migraines. In studies, most patients tolerated zavegepant well. The FDA has approved it for sudden migraine attacks, indicating general safety. However, some patients experienced side effects, though specific details are limited. Overall, the treatment appears safe based on its use for migraines, but discussing potential risks with a doctor is advisable.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cluster headaches, such as oxygen therapy and triptans, Zavegepant is unique because it is a CGRP receptor antagonist. This means it works by blocking the calcitonin gene-related peptide, a protein that plays a key role in pain transmission and inflammation associated with headaches. Researchers are excited about Zavegepant because it offers a new mechanism of action that could provide relief more effectively and with fewer side effects than current options. Additionally, Zavegepant is administered nasally, which may offer faster relief compared to oral medications.

What evidence suggests that zavegepant might be an effective treatment for cluster headache?

Research has shown that zavegepant might help treat cluster headaches. Earlier studies found that zavegepant works by blocking a protein called CGRP, which contributes to migraine pain. This action could reduce the severity and frequency of headache attacks. Users of zavegepant for migraines have reported quick pain relief. Although specific data on cluster headaches is still being collected, the positive results in migraine treatment suggest potential effectiveness for cluster headaches. Participants in this trial will receive zavegepant to evaluate its effectiveness for cluster headaches.678910

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zavegepant intranasal spray for the acute treatment of episodic cluster headache

Up to 10 weeks

Follow-up

Participants are monitored for headache response rate and treatment failure endpoints

Up to 10 weeks

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

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.

homvee.acf.gov

homvee.acf.gov/home

What is Home Visiting Evidence of Effectiveness? | Home ...

This video explains how HomVEE reviews research, rates model effectiveness, and determines which models meet criteria for evidence of effectiveness.

EFFECTIVENESS Definition & Meaning

The meaning of EFFECTIVENESS is the quality or state of being effective. How to use effectiveness in a sentence.

Effectiveness of Covid-19 Vaccines against the B.1.617.2 ...

Data on the effectiveness of Covid-19 vaccines against clinical outcomes with this variant have been limited. In this study, we aimed to ...

Effectiveness

Effectiveness or effectivity. When something is deemed effective, it means it has an intended or expected outcome, or produces a deep, vivid impression.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24330006/

Effectiveness and safety of novel oral anticoagulants as ...

NOACs have comparable efficacy to that of VKAs, and are associated with a significantly lower risk of bleeding complications,

View PDF

Zavegepant was demonstrated to be effective in the acute treatment of migraine, as measured by superiority to placebo on the co-primary efficacy ...

Intranasal CGRP Antagonist Is Approved for the Treatment ...

The safety of treating more than 8 migraines in 30 days with zavegepant has not been established, and patients should not exceed 10 mg in 24 ...

Zavegepant Monograph for Professionals

Zavegepant reference guide for safe and effective use from the American Society of Health-System Pharmacists (AHFS DI).

Zavegepant 10 mg Nasal Spray is Effective for the Acute ...

Zavegepant nasal spray was effective for the acute treatment of migraine in participants with ≥4 and those with <4 attacks per month on the ...

Zavegepant 10mg Nasal Spray for Migraine: Phase 3 Results

This randomized, placebo-controlled, phase 3 trial compared the effectiveness, safety, and time course of zavegepant nasal spray in the acute ...