Clinical trial NCT03742024: Study of Pediatric Migraine: The Pediatric Migraine Registry
Official title: Observational Study of Pediatric Migraine: The Pediatric Migraine Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2018-11-15
Enrollment: 201
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Migraine frequency
timeFrame: Approximately 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Wilmington
country: United States
facility: Nemours Alfred I duPont Hospital For Children Neurology
state: Delaware
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Louisville
country: United States
facility: University of Louisville Health Sciences center
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Medical Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital, The Miriam Hospital
state: Rhode Island
city: Columbia
country: United States
facility: University of South Carolina at Columbia
state: South Carolina
city: Burlington
country: United States
facility: University of Vermont School of Medicine
state: Vermont
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Duke University
name: Christoph Hornik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California at San Francisco
name: Amy Gelfand, MD
role: PRINCIPAL_INVESTIGATOR
References: