Status:
COMPLETED
Mind and Body Approaches to Pain Reduction in Youth With Migraine
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Headache, Migraine
Migraine
Eligibility:
All Genders
10-17 years
Phase:
PHASE2
Brief Summary
The overarching objective of this protocol is to identify and understand the neural and pain processing mechanisms by which youth with migraine improve in response to preventive treatment. The study d...
Detailed Description
Pediatric migraine is a prevalent disorder that results in significant pain and disability for children and adolescents. Despite the prevalence and cost, commonly used pharmacologic treatments to trea...
Eligibility Criteria
Inclusion
- Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders, 3rd Edition (beta) (ICHD-3b) criteria
- Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 8 and ≤ 28
- PedMIDAS: PedMIDAS Disability Score \> 10, indicating at least mild disruption in daily activities and \< 140, indicating extreme disability that may require more comprehensive, multi-component therapy
- English speaking: able to complete interviews and questionnaires in English
Exclusion
- Continuous migraine defined as an unrelenting headache for a 28 day period
- Weight less than 30 kg or greater than 120 kg, or weight/size incompatible with magnetic resonance imaging (MRI) scanner
- Must agree not to take non-specific acute medication, such as nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month
- No current prophylactic anti-migraine medication within a period equivalent to \< 5 half-lives of that medication before entering the screening phase, and agree to not begin a migraine prevention medication during the study period
- Current use of the following medications/products: opioids, antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, sedatives, tramadol, nutraceuticals
- Known history of allergic reaction or anaphylaxis to amitriptyline
- Abnormal findings on electrocardiogram (ECG) at baseline, particularly lengthening of the QT interval ≥ 450 msec
- Orthodontic braces, metallic or electronic implants, or other metal objects in the body which obscure or interfere with the MRI, or pose a risk from heating, movement, or malfunction in the MRI environment
- Claustrophobia
- Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods)
- Diagnosis of epilepsy or other neurological diseases
- Inability to learn how to swallow pills using behavioral techniques (if indicated)
- Present psychiatric disease as defined by the Diagnostic and Statistical Manual (DSM) IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, attention deficit hyperactivity disorder (ADHD), or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study
Key Trial Info
Start Date :
October 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03472092
Start Date
October 2 2018
End Date
June 30 2025
Last Update
August 26 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229