Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2012

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 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.
• Active Comparator: 2
  • Behavioral headache education

Primary Measures

• Headache diaries assess headache frequency
  • Time Frame: completed every week up to week 20, 1 month prior to 3, 6, 9, and 12 month follow-up
    Safety Issue?: No
• Pediatric Migraine Disability Assessment (PedMIDAS) evaluates the impact of headaches on life activities.
  • Time Frame: completed at baseline, week 20, Month 3, 6, 9, and 12
    Safety Issue?: No

Secondary Measures

• The Child Depression Inventory
  • Time Frame: completed at baseline, week 20, Month 3, 6, 9, and 12
    Safety Issue?: No
• PedsQL measures the impact of chronic illness and quality of life
  • Time Frame: completed at baseline, week 20, Month 3, 6, 9, and 12
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Overall Clinical Trial Officials and Contacts

Scott Powers, PhD, ABPP Principal Investigator Children's Hospital Medical Center, Cincinnati  

Overall Contact: Janelle Allen 513-636-1840 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00389038

Study ID Number: R01NS050536

ClinicalTrials.gov Identifier: NCT00389038

Health Authority: United States: Federal Government

Cincinnati Children's Hospital Lab web page