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CGRP Antagonist

Zavegepant Treatment for Migraine

Phase 4

Waitlist Available

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

Study 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.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 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24-32 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Functional disability level in 2 hours

Functional disability level in 4 hours

Headache relief in 2 hours

+1 more

Secondary outcome measures

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%

Study treatment Arm

Zavegepant 10 mg

Placebo

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,237 Previous Clinical Trials

3,771,704 Total Patients Enrolled

10 Trials studying Migraine

81,806 Patients Enrolled for Migraine

Todd Schwedt, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

333 Total Patients Enrolled

1 Trials studying Migraine

292 Patients Enrolled for Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently recruiting participants for this ongoing medical study?

"As per clinicaltrials.gov, the ongoing trial is not currently seeking participants. Its initial posting was on May 1st, 2024 and its latest update occurred on May 2nd, 2024. Despite this specific trial being inactive for enrollment presently, there are a total of 174 other active trials welcoming new participants at present."

Answered by AI