Zavegepant for Cluster Headache
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive zavegepant intranasal spray for the acute treatment of episodic cluster headache
Follow-up
Participants are monitored for headache response rate and treatment failure endpoints
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
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.
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 ...
7.
drugtopics.com
drugtopics.com/view/intranasal-cgrp-antagonist-is-approved-for-the-treatment-of-acute-migrainesIntranasal 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 ...
10.
physiciansweekly.com
physiciansweekly.com/post/zavegepant-10mg-nasal-spray-for-migraine-phase-3-resultsZavegepant 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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.