Study of Pediatric Migraine: The Pediatric Migraine Registry

NCT ID: NCT03742024

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-05

Study Completion Date

2021-02-08

Brief Summary

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This is a multi-center registry that will prospectively collect regulatory compliant data from children and adolescents with migraine. This study will enroll approximately 200 participants from approximately 20 sites and will examine migraine symptoms, therapeutics used, and biomarkers associated with migraine.

Detailed Description

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Conditions

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Migraine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children and adolescents

Children and adolescents between the ages of 4 and 17 years old (inclusive)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 4 to 17 years of age inclusive at the time of enrollment visit
* Meets International Classification of Headache Disorders, 3rd edition criteria for migraine with or without aura
* Guardian provides informed consent/HIPAA
* Participant provides assent if developmentally appropriate and required by the institutional review board

Exclusion Criteria

* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Hornik, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Amy Gelfand, MD

Role: PRINCIPAL_INVESTIGATOR

University of California at San Francisco

Locations

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University of California at San Francisco

San Francisco, California, United States

Site Status

Colorado Springs Neurological Associates

Colorado Springs, Colorado, United States

Site Status

Nemours Alfred I duPont Hospital For Children Neurology

Wilmington, Delaware, United States

Site Status

Nicklaus Children's Hospital

Miami, Florida, United States

Site Status

University of Louisville Health Sciences center

Louisville, Kentucky, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Michigan Headache & Neurological Institute

Ann Arbor, Michigan, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Akron Children's Hospital

Akron, Ohio, United States

Site Status

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

The Cleveland Clinic Children's Hospital

Cleveland, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Rhode Island Hospital, The Miriam Hospital

Providence, Rhode Island, United States

Site Status

University of South Carolina at Columbia

Columbia, South Carolina, United States

Site Status

University of Vermont School of Medicine

Burlington, Vermont, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00100205

Identifier Type: -

Identifier Source: org_study_id

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