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Study of Pediatric Migraine: The Pediatric Migraine Registry

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ClinicalTrials.gov Identifier: NCT03742024
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Migraine

Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Months
Official Title: Observational Study of Pediatric Migraine: The Pediatric Migraine Registry
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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



Primary Outcome Measures :
  1. Migraine frequency [ Time Frame: Approximately 20 months ]
    Number of days per month participant experiences migraine


Biospecimen Retention:   Samples With DNA
Whole blood, buccal swab, urine, stool.


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742024


Contacts
Contact: Amanda Utevsky, PhD 919-668-5052 amanda.utevsky@duke.edu
Contact: Anthony Cunningham 919-668-8320 anthony.cunningham@duke.edu

Locations
United States, Colorado
Colorado Springs Neurological Associates Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Jodi Ventimiglia    719-389-1126      
Contact: Lisa Deschaine    719-389-1129      
Principal Investigator: Christen Kutz         
Sponsors and Collaborators
Duke University
University of California, San Francisco
Investigators
Principal Investigator: Christoph Hornik, MD Duke University
Principal Investigator: Amy Gelfand, MD University of California at San Francisco

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03742024     History of Changes
Other Study ID Numbers: Pro00100205
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases