Phase
Condition
Headaches
Migraine (Pediatric)
Chronic Pain
Treatment
home practice e-health
home practice handout
phone call
Clinical Study ID
Ages 10-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis: Migraine with or without aura or chronic migraine that meets theInternational Classification of Headache Disorders(ICHD) criteria
Frequency: Headache frequency based upon prospective headache diary of 28 days mustbe ≥ 4 and ≤ 28.
PedMIDAS: PedMIDAS Disability Score > 4, indicating at least mild disruption indaily activities and < 140, indicating extreme disability that may require morecomprehensive, multi-component therapy
Use of one or more of the following prescribed nutraceuticals and/or preventiveanti-migraine medications at the time or randomization or be on a stable dose of oneor more of the following throughout the 12 weeks of the study [Vitamin B2 (Riboflavin), Co-Q 10 (Coenzyme Q10), Magnesium (Mg), Vitamin D2 or D3 (Erocalciferol/Cholecalciferol), Depakote (Divalproate), Inderal (Propanerol),Elavil ((Amitripyline), Topamax (Topiramate), Periactin (Cyproheptadine)]
Language: English speaking, able to complete interviews and questionnaires inEnglish
Exclusion
Exclusion Criteria:
Continuous migraine defined as unrelenting headache for a 28 day period
Must agree not to take non-specific acute medication, such as NSAIDS (e.g.,ibuprofen), more than 3 times per week, or migraine specific acute medications, suchas triptans, more than 6 times per month (to prevent medication overuse headache)
PedMIDAS Disability Score > 140, indicating extreme disability that may require morecomprehensive, multi-component therapy
Youth who are pregnant, or those who are sexually active and not using a medicallyaccepted form of contraception (barrier or hormonal methods)
Present severe psychiatric disease, alcohol or drug dependence, or documenteddevelopmental delays or impairments (e.g., autism, cerebral palsy, or mentalretardation) or other circumstances, that, in the opinion of the investigator, wouldinterfere with adherence to study requirements or safe participation in the study
Study Design
Study Description
Connect with a study center
University of Colorado/Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado/Children's Hospital Colorado
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
United StatesActive - Recruiting
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