Pediatric Chronic Headache Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00389038
First received: October 16, 2006
Last updated: April 21, 2011
Last verified: April 2011

October 16, 2006
April 21, 2011
October 2006
August 2012   (final data collection date for primary outcome measure)
Headache diaries assess headache frequency. [ Time Frame: Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits. ] [ Designated as safety issue: No ]
  • Headache diaries assess headache frequency
  • Pediatric Migraine Disability Assessment (PedMIDAS) evaluates the impact of headaches on life activities.
Complete list of historical versions of study NCT00389038 on ClinicalTrials.gov Archive Site
  • The Child Depression Inventory. [ Time Frame: Completed at Baseline, Week 20, and Months 3, 6, 9, and 12. ] [ Designated as safety issue: No ]
  • The PedsQL measures the impact of chronic illness and quality of life. [ Time Frame: Completed at Baseline, Week 20, and Months 3, 6, 9, and 12. ] [ Designated as safety issue: No ]
  • Pediatric Migraine Disability Assessment (PedMIDAS) evaluates the impact of headaches on life activities. [ Time Frame: Completed at Baseline, Week 20, and Months 3, 6, 9, and 12. ] [ Designated as safety issue: No ]
  • The Child Depression Inventory
  • PedsQL measures the impact of chronic illness and quality of life.
Not Provided
Not Provided
 
Pediatric Chronic Headache Trial
Drug and Non-Drug Treatment of Pediatric Chronic Headache

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.

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 stress. Very little is known about the most effective types of treatment for CDH in children and adolescents. Development of effective interventions for youth with CDH could potentially prevent the progression of a very painful and costly condition into adulthood. Treatments combining pharmacological (drug) interventions with behavior change have been found effective in treating adults with chronic pain, including headaches, but have been understudied in children.

The goal of this randomized, controlled clinical trial is to determine the efficacy of combined behavioral and drug treatment of CDH in youth ages 10 to 17. In the study, scientists will investigate if a combination of pain coping skills training (CST) and the drug amitriptyline (AMI)——CST-AMI——is effective in reducing headache frequency, functional disability, and symptoms of depression. More specifically, the researchers will evaluate if CST-AMI is superior to AMI combined with an attention control (ATT). The CST will mainly focus on learning skills for coping with pain, and the ATT will focus on understanding chronic headaches and lifestyle information.

Participants will be randomly assigned to one of the two treatment groups: CST-AMI or ATT-AMI. Those assigned to CST-AMI will complete 8 weekly sessions of coping training and 2 monthly maintenance-promoting sessions. Sessions will focus on teaching biofeedback, muscle relaxation techniques, imagery, distraction, activity pacing, problem solving, and calming techniques, using a treatment manual developed and tested in youth with CDH. Those assigned to ATT-AMI will receive the same amount of therapist support and attention but not the active behavioral training. All participants will receive the study medication, AMI.

Headache frequency, functional disability, pain and headache characteristics, quality of life, and symptoms of depression will be assessed before and after treatment, and reassessed at 3, 6, 9, and 12 months. For participants, duration of the study——which includes treatment and follow-up phases——lasts about 18 months. The treatment phase includes 12 study visits and the follow-up phase includes 4 study visits.

The long-term objective of this research is to establish effective treatments for CDH in youth that lead to significantly reduced headache frequency and functional disability.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Headache
  • Behavioral: Coping Skills Training
    Behavioral Treatment 1 (coping skills training)--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year.
  • Behavioral: Headache Education
    Behavioral Treatment 2 (headache education)
  • Drug: Amitriptyline
    Amitriptyline: up to 1 mg/kg capsule taken once daily at bedtime. Taken up to Week 20. After Week 20 medications and doses may change with standard care.
  • Active Comparator: Coping Skills Training + Amitriptyline
    Behavioral coping skills training--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year.
    Interventions:
    • Behavioral: Coping Skills Training
    • Drug: Amitriptyline
  • Active Comparator: Headache Education + Amitriptyline
    Behavioral headache education
    Interventions:
    • Behavioral: Headache Education
    • Drug: Amitriptyline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
132
September 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00389038
R01NS050536, 1R01NS050536-01A1
Yes
Scott W. Powers, PhD ABPP FAHS, Professor, Co-Director of the Headache Center, Cincinnati Children's Hospital Medical Center
Children's Hospital Medical Center, Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Scott W. Powers, PhD, ABPP, FAHS Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP