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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 : May 13, 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

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

Locations
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United States, California
University of California at San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Isra Saeed    415-885-7832    Isra.saeed@ucsf.edu   
Principal Investigator: Samantha Irwin, MD         
Sub-Investigator: Amy Gelfand, MD         
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         
United States, Delaware
Nemours Alfred I duPont Hospital For Children Neurology Recruiting
Wilmington, Delaware, United States, 19803
Contact: Tara Pezzuto       tara.pezzuto@nemours.org   
Principal Investigator: Ross Judith         
Sub-Investigator: Pezzuto Tara         
United States, Kentucky
University of Louisville Health Sciences center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Lauren Evanczyk       lauren.evanczyk@ulp.org   
Principal Investigator: Elizabeth Doll, MD         
United States, Michigan
Michigan Headache & Neurological Institute Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Shawn Szalay, RN/BSN, CCRP    734-677-6000 ext 128    sszalay@mhni.com   
Principal Investigator: Joel Saper, MD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Madeline Boorigie    816-302-3343    meboorigie@cmh.edu   
Contact: Misty Whisenhunt    816-302-3330    mdwhisehunt@cmh.edu   
Principal Investigator: Jennifer Bickel, MD         
Cardinal Glennon Children's Medical Center Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Kimberly Stieglitz    314-577-5338    Kim.Stieglitz@ssmhealth.com   
Principal Investigator: Deepa Arun, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Kelsey Fillman    402-552-9894    kelsey.fillman@unmc.edu   
Principal Investigator: Geetanjali Rathore, MD         
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 48109
Contact: Danielle Morgan    330-543-0460    dmorgan@akronchildrens.org   
Principal Investigator: Maria Victorio         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Blanca Marquez de Prado    267-425-1962    marquezdeb@email.chop.edu   
Principal Investigator: Christina Szperka, MD         
United States, Rhode Island
Rhode Island Hospital, The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Erin Ryan    401-444-9264    erin.ryan@lifespan.org   
Principal Investigator: Karen Kerman, MD         
United States, South Carolina
University of South Carolina at Columbia Recruiting
Columbia, South Carolina, United States, 29203
Contact: Julia Adams, BSN, RN, CCRC    803-434-3109    julia.adams@PrismaHealth.org   
Principal Investigator: Robert Nahouraii, MD         
United States, Vermont
University of Vermont School of Medicine Recruiting
Burlington, Vermont, United States, 05401
Contact: Ian McHale    802-656-9094    Ian.mchale@med.uvm.edu   
Principal Investigator: Deborah Hirtz, MD         
Sponsors and Collaborators
Duke University
University of California, San Francisco
Investigators
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Principal Investigator: Christoph Hornik, MD Duke University
Principal Investigator: Amy Gelfand, MD University of California at San Francisco

Additional Information:

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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: May 13, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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