Pediatric Chronic Headache Trial

Headache Clinical Trial

Official title:

Drug and Non-Drug Treatment of Pediatric Chronic Headache

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00389038
• Other study ID #: R01NS050536
• Secondary ID: 1R01NS050536-01A
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 16, 2006
• Last updated: April 21, 2011
• Start date: October 2006
• Est. completion date: September 2012

Study information

• Verified date: April 2011
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Cincinnati Children's Hospital Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Mail Location 3015	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache diaries assess headache frequency.		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.	No
Secondary	The Child Depression Inventory.		Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.	No
Secondary	The PedsQL measures the impact of chronic illness and quality of life.		Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.	No
Secondary	Pediatric Migraine Disability Assessment (PedMIDAS) evaluates the impact of headaches on life activities.		Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.	No

External Links

•   Cincinnati Children's Hospital Lab Web Page