Study of Pediatric Migraine: The Pediatric Migraine Registry
Observational Study of Pediatric Migraine: The Pediatric Migraine Registry
1 other identifier
observational
201
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2018
CompletedFirst Posted
Study publicly available on registry
November 15, 2018
CompletedStudy Start
First participant enrolled
December 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2021
CompletedApril 13, 2021
April 1, 2021
2.2 years
November 12, 2018
April 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Migraine frequency
Number of days per month participant experiences migraine
Approximately 12 months
Study Arms (1)
Children and adolescents
Children and adolescents between the ages of 4 and 17 years old (inclusive)
Eligibility Criteria
Participants aged 4-17 years old (inclusive) diagnosed with migraine with or without aura will be eligible for participation in this study.
You may qualify if:
- 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
You may not qualify if:
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- University of California, San Franciscocollaborator
Study Sites (19)
University of California at San Francisco
San Francisco, California, 94158, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
Nemours Alfred I duPont Hospital For Children Neurology
Wilmington, Delaware, 19803, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
University of Louisville Health Sciences center
Louisville, Kentucky, 40202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Akron Children's Hospital
Akron, Ohio, 48109, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
The Cleveland Clinic Children's Hospital
Cleveland, Ohio, 44195, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital, The Miriam Hospital
Providence, Rhode Island, 02903, United States
University of South Carolina at Columbia
Columbia, South Carolina, 29203, United States
University of Vermont School of Medicine
Burlington, Vermont, 05401, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Biospecimen
Whole blood, buccal swab, urine, stool.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Hornik, MD
Duke University
- PRINCIPAL INVESTIGATOR
Amy Gelfand, MD
University of California at San Francisco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 20 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2018
First Posted
November 15, 2018
Study Start
December 5, 2018
Primary Completion
February 8, 2021
Study Completion
February 8, 2021
Last Updated
April 13, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share