Pediatric Chronic Headache Trial

Status unconfirmed · Phase 3

Conditions studied: Headache

In brief

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.

Key facts

Study ID

NCT00389038

Run by

Children's Hospital Medical Center, Cincinnati

People needed

132

Starts

2006-10-01

Expected to finish

2012-09-01

Last updated by the study team

2011-04-25

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Mail Location 3015 — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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