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CGRP Antagonist
Zavegepant for Migraine
Phoenix, AZ
Phase 4
Recruiting
Led By Todd Schwedt, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
Meets ICHD 3 diagnostic criteria for migraine with or without aura
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24-32 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial aims to study how well and how tolerable zavegepant is in treating migraine attacks in people who are already using CGRP migraine preventive treatments.
See full description
Who is the study for?
This trial is for adults who experience 2-8 migraine attacks monthly and have been on stable CGRP-targeting preventive medications for at least two months. They must meet the criteria for migraines with or without aura and can be using additional stable migraine preventives.Check my eligibility
What is being tested?
The study tests Zavegepant's effectiveness in treating acute migraines among those already using other CGRP-targeting preventive treatments. It aims to understand how well Zavegepant works when taken during a migraine attack by people on these preventives.See study design
What are the potential side effects?
While specific side effects of Zavegepant are not listed here, common ones may include nausea, dry mouth, dizziness, fatigue, and potential hypersensitivity reactions in those allergic to its components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with migraines, with or without aura.
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I experience 2-8 migraine attacks each month.
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I experience 4 or more migraine days monthly.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 24-32 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24-32 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Functional disability level in 2 hours
Functional disability level in 4 hours
Headache relief in 2 hours
+1 moreSecondary study objectives
Adverse events
Discontinuation due to adverse events
Serious adverse events
Side effects data
From 2021 Phase 3 trial • 1978 Patients • NCT0457106021%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zavegepant 10 mg
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Zavegepant TreatmentExperimental Treatment1 Intervention
Participants will receive zavegepant to treat up to 8 migraine attacks over 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zavegepant
2019
Completed Phase 3
~4150
Find a Location
Closest Location:Mayo Clinic in Arizona· Scottsdale, AZ· 1402 miles
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,422 Previous Clinical Trials
3,222,307 Total Patients Enrolled
11 Trials studying Migraine
81,876 Patients Enrolled for Migraine
Todd Schwedt, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
334 Total Patients Enrolled
1 Trials studying Migraine
292 Patients Enrolled for Migraine