Pediatric Chronic Headache Trial

• Status: Unknown status
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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