Status:
UNKNOWN
Pediatric Chronic Headache Trial
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Headache
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to evaluate the efficacy of combined behavioral and pharmacological treatment on chronic daily headache in children ages 10 to 17.
Detailed Description
Chronic daily headache (CDH)--defined as having headaches 15 or more days per month--is a frequent and debilitating condition in children that results in severe decreased quality of life and emotional...
Eligibility Criteria
Inclusion
- diagnosis of chronic daily headache based on definition of 15 or more headache days per month measured by a prospective daily headache diary
- females or males between the ages of 10-17
- PedMIDAS Disability Score \> 20, indicating at least moderate disruption in daily activities
Exclusion
- medication overuse as defined in the ICHD-II criteria (NSAID or other simple analgesic on ≥ 15 days/ month for \>3 months; triptan intake in any formulation ≥ 10 days/month on a regular basis of ≥ 3 months)
- current treatment with amitriptyline
- no other current prophylactic antimigraine medication within a period equivalent to \< 5 half-lives of that medication before entering the screening phase
- other chronic pain condition such as juvenile primary fibromyalgia syndrome, complex regional pain syndrome-II
- abnormal findings on EKG
- current or past history of severe orthostatic intolerance or severe levels of orthostatic dysregulation (orthostatic hypotension or postural orthostatic tachycardia syndrome)
- significant documented developmental delay or impairments such as autism, cerebral palsy or mental retardation
- present or lifetime psychiatric diagnosis that meets DSM-IV criteria for bipolar disorder, major depressive disorder or psychosis
- PedMIDAS Disability Score of \> 140, indicating need for multi-systemic therapies to address very significant level of disability
- youth who are pregnant, or those females who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods) or do not agree to be abstinent during the study
- disallowed medications/products: opioids, antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, sedatives, tramadol
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00389038
Start Date
October 1 2006
End Date
September 1 2012
Last Update
April 25 2011
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Mail Location 3015
Cincinnati, Ohio, United States, 45229-3039