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NCT03742024 Clinical Trial

Study of Pediatric Migraine: The Pediatric Migraine Registry

Migraine Clinical Trial

Official title:
Observational Study of Pediatric Migraine: The Pediatric Migraine Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03742024
Other study ID # Pro00100205
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 5, 2018
Est. completion date February 8, 2021

Study information
Verified date April 2021
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 201
Est. completion date February 8, 2021
Est. primary completion date February 8, 2021
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Akron Children's Hospital Akron Ohio
United States Michigan Headache & Neurological Institute Ann Arbor Michigan
United States University of Maryland Baltimore Maryland
United States University of Vermont School of Medicine Burlington Vermont
United States Cincinnati Children's Hospital Cincinnati Ohio
United States The Cleveland Clinic Children's Hospital Cleveland Ohio
United States Colorado Springs Neurological Associates Colorado Springs Colorado
United States University of South Carolina at Columbia Columbia South Carolina
United States Children's Mercy Hospital Kansas City Missouri
United States University of Louisville Health Sciences center Louisville Kentucky
United States Nicklaus Children's Hospital Miami Florida
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Rhode Island Hospital, The Miriam Hospital Providence Rhode Island
United States Cardinal Glennon Children's Medical Center Saint Louis Missouri
United States University of California at San Francisco San Francisco California
United States Seattle Children's Hospital Seattle Washington
United States Nemours Alfred I duPont Hospital For Children Neurology Wilmington Delaware

Sponsors (2)
Lead Sponsor Collaborator
Duke University University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Migraine frequency Number of days per month participant experiences migraine Approximately 12 months
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