Pediatric Chronic Headache Trial

April 21, 2011 updated by: Children's Hospital Medical Center, Cincinnati

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Mail Location 3015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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: Headache Education + Amitriptyline
Behavioral 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.
Behavioral: Headache Education
Behavioral Treatment 2 (headache education)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Time Frame
The Child Depression Inventory.
Time Frame: Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.
Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.
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.
Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.
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.
Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Scott W. Powers, PhD, ABPP, FAHS, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

April 25, 2011

Last Update Submitted That Met QC Criteria

April 21, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NS050536 (U.S. NIH Grant/Contract)
  • 1R01NS050536-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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