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CGRP Antagonist

Zavegepant for Migraine

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.

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.
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.
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 below
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24-32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24-32 weeks for reporting.

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 more
Secondary study objectives
Adverse events
Discontinuation due to adverse events
Serious adverse events

Side effects data

From 2021 Phase 3 trial • 1978 Patients • NCT04571060
21%
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

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,059,975 Total Patients Enrolled
10 Trials studying Migraine
81,806 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
~133 spots leftby Mar 2027
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