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Clinical Trials/NCT05415020
NCT05415020
Recruiting
N/A

Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine

Mayo Clinic1 site in 1 country60 target enrollmentJune 29, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Migraine
Sponsor
Mayo Clinic
Enrollment
60
Locations
1
Primary Endpoint
Number of Interested Participants that are Enrolled
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.

Registry
clinicaltrials.gov
Start Date
June 29, 2022
End Date
August 14, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yohannes Woubishet Woldeamanuel

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • have chronic migraine for a minimum of 1-year
  • aged 18 years and older

Exclusion Criteria

  • other headache disorders including secondary headache disorders
  • children younger than 18 years old
  • current pregnancy

Outcomes

Primary Outcomes

Number of Interested Participants that are Enrolled

Time Frame: 12 weeks

Recruitment rate (Feasibility Outcome)

Acceptability

Time Frame: 12 weeks

Retention rate

Secondary Outcomes

  • Mean change from baseline monthly migraine frequency(12 weeks)
  • Migraine severity(12 weeks)

Study Sites (1)

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