Pediatric Chronic Headache Trial
Unknown statusPhase 3NCT00389038
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Drug and Non-Drug Treatment of Pediatric Chronic Headache
- Conditions
- Interventions
- Behavioral: Coping Skills Training
- Behavioral: Headache Education
- Drug: Amitriptyline
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Start date
- 2006-10
- Primary completion
- 2012-08
- Sex
- All
- Age range
- from 10 Years to 17 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00389038