Study of Pediatric Migraine: The Pediatric Migraine Registry

Observational Study of Pediatric Migraine: The Pediatric Migraine Registry

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.

Study Overview

• Status: Completed
• Conditions: Migraine

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California at San Francisco
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours Alfred I duPont Hospital For Children Neurology
  • Florida
    • Miami, Florida, United States, 33155
      • Nicklaus Children's Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Health Sciences Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Headache & Neurological Institute
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
    • Saint Louis, Missouri, United States, 63104
      • Cardinal Glennon Children's Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • Ohio
    • Akron, Ohio, United States, 48109
      • Akron Children's Hospital
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati CHildren's Hospital
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Children's Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital, The Miriam Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • University of South Carolina at Columbia
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont School of Medicine
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants aged 4-17 years old (inclusive) diagnosed with migraine with or without aura will be eligible for participation in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children and adolescents; Children and adolescents between the ages of 4 and 17 years old (inclusive)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine frequency	Number of days per month participant experiences migraine	Approximately 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: christoph Hornik, MD, Duke University; Principal Investigator: Amy Gelfand, MD, University of California at San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): February 8, 2021
• Study Completion (Actual): February 8, 2021

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: Pro00100205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No