Pediatric Migraine Registry Program
What is pediatric migraine and how many children does it affect? Migraine is common among children, however, it often goes undiagnosed or untreated. About 60% of adolescents complain of headache at some point in their lives, with 8% of children being diagnosed with having migraine. Prior to puberty, the proportion of migraine among boys and girls are about the same. After puberty, in teenage years, migraine is seen to be more prevalent in girls than boys.1
Migraine symptoms in children
In younger children, many of the symptoms are often GI (gastrointestinal) related, with complaints of nausea, vomiting and stomach pain. Some children experience a more “classic” presentation of migraine like adults do, with one-sided pain, photophobia and phonophobia. However, it is common for children to experience pain on both sides of the head along with sensitivity to light and sound.1
Study of pediatric migraine: Pediatric Migraine Registry Program
Duke University in collaboration with the University of California, San Francisco are conducting a study, whose purpose is to create a pediatric migraine registry. It is prospected to collect regulatory compliant data from children and adolescents with migraine across 20 different sites. This study will examine migraine symptoms, therapeutics used, and biomarkers associated with migraine. This is an observational study with an estimated enrollment of 200 participants.
This study is looking for children and adolescents between the ages of 4 and 17 years old, who have been diagnosed with having migraine with or without aura. Eligibility requirements also include:
- Guardian provides informed consent/HIPAA
- Participant provides assent if developmentally appropriate and required by the institutional review board
- All genders are eligible
Exclusion criteria includes any condition that would make the participant, in the opinion of the investigator, unsuitable for the study.
Migraine frequency will be measured over a course of 20 months to determine the number of days per month the participant experiences migraine. The end date of this study is scheduled for May 1, 2021.
- Kids/parents may have access to future clinical trials of both drugs and interventions
- Biobanking to help identify biomarkers
- Access to migraine diary application and validation of the migraine diary application for future use
- Increases awareness about migraine in kids
- Increase in disease funding
- Increase of treatment options
- Access to kids for future studies (needed to bring new drugs to market)
The importance of a pediatric migraine registry
Not enough is known about pediatric migraine, how many children, adolescents, and teens are truly affected by it and which therapeutics are best in treating them. Currently, the types of therapies available to treat pediatric migraine are very limited. Having a registry of children and adolescents who have been diagnosed with migraine with or without aura could help aid in disease funding, which in turn could increase the number of treatment options. This is also a great way to raise and increase awareness about migraine in children. So many of our youth suffer through the school day in pain, with GI symptoms or other disabling symptoms associated with migraine.
How to enroll
If you have a child who has been diagnosed with either migraine with or without aura, please reach out to any of the two contacts listed below. Please refer to this study by its ClinicalTrials.gov identifier (NCT number) NCT03742024.
Amanda Utevsky, PhD 919-668-5052 email@example.com
Anthony Cunningham 919-668-8320 firstname.lastname@example.org
This study is currently recruiting in the following locations:
- California – University of California at San Francisco
- Colorado – Colorado Springs Neurological Associates
- Delaware – Nemours Alfred I duPont Hospital For Children Neurology
- Kentucky – University of Louisville Health Sciences Center
- Michigan – Michigan Headache & Neurological Institute
- Missouri – Children’s Mercy Hospital and Cardinal Glennon Children’s Medical Center
- Nebraska – University of Nebraska Medical Center
- Ohio – Akron Children’s Hospital
- Pennsylvania – Children’s Hospital of Philadelphia
- Rhode Island – Rhode Island Hospital, The Miriam Hospital
- South Carolina – University of South Carolina at Columbia
- Vermont – University of Vermont School of Medicine
For more information in this study and patient registry, visit https://clinicaltrials.gov/ct2/show/study/NCT03742024. Please refer to this study by its ClinicalTrials.gov identifier (NCT number) NCT03742024.
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