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Pediatric Chronic Headache Trial

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ClinicalTrials.gov Identifier: NCT00389038
Recruitment Status : Unknown
Verified April 2011 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was:  Active, not recruiting
First Posted : October 17, 2006
Last Update Posted : April 25, 2011
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE October 16, 2006
First Posted Date  ICMJE October 17, 2006
Last Update Posted Date April 25, 2011
Study Start Date  ICMJE October 2006
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
  • Headache diaries assess headache frequency
  • Pediatric Migraine Disability Assessment (PedMIDAS) evaluates the impact of headaches on life activities.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
  • The Child Depression Inventory. [ Time Frame: 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
  • The Child Depression Inventory
  • PedsQL measures the impact of chronic illness and quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Chronic Headache Trial
Official Title  ICMJE Drug and Non-Drug Treatment of Pediatric Chronic Headache
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Headache
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 16, 2006)
132
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2012
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389038
Other Study ID Numbers  ICMJE R01NS050536( U.S. NIH Grant/Contract )
1R01NS050536-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott W. Powers, PhD ABPP FAHS, Professor, Co-Director of the Headache Center, Cincinnati Children's Hospital Medical Center
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Scott W. Powers, PhD, ABPP, FAHS Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date April 2011

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