HeadachePhase 3NCT00389038
Pediatric Chronic Headache Trial
A Phase 3 study testing Coping Skills Training, Headache Education and Amitriptyline in people with Headache, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Headache
- What is being tested?
- Coping Skills Training, Headache Education and Amitriptyline
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Mail Location 3015
Cincinnati, Ohio, 45229-3039
About this study
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.
Read the 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.
- Conditions
- Headache
- Being tested
- Coping Skills Training, Headache Education, Amitriptyline
- Keywords
- headache, coping skills training, amitriptyline, attention control
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Skills TrainingBehavioural
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 EducationBehavioural
Behavioral Treatment 2 (headache education)
AmitriptylineDrug
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 group | Role | What they receive |
|---|---|---|
| Coping Skills Training + Amitriptyline | Active comparator | 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. Receives: Behavioral: Coping Skills Training; Drug: Amitriptyline |
| Headache Education + Amitriptyline | Active comparator | Behavioral headache education Receives: Behavioral: Headache Education; Drug: Amitriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache diaries assess headache frequency.
Measured: 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 outcomes (3)
The Child Depression Inventory.
Measured: Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.
The PedsQL measures the impact of chronic illness and quality of life.
Measured: 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.
Measured: Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Investigators
- Scott W. Powers, PhD, ABPP, FAHS, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389038
- Sponsor's protocol ID
- R01NS050536
- Other IDs
- 1R01NS050536-01A1
- Status last verified
- Apr 2011
- First submitted
- 16 Oct 2006
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rettig EK, Ergun G, Warfield JR, Slater SK, LeCates SL, Kabbouche MA, Kacperski J, Hershey AD, Powers SW. Predictors of Improvement in Pediatric Chronic Migraine: Results from the Cognitive-Behavioral Therapy and Amitriptyline Trial. J Clin Psychol Med Settings. 2022 Mar;29(1):113-119. doi: 10.1007/s10880-021-09782-4. Epub 2021 May 24.
PubMed 34028656Kroner JW, Peugh J, Kashikar-Zuck SM, LeCates SL, Allen JR, Slater SK, Zafar M, Kabbouche MA, O'Brien HL, Shenk CE, Kroon Van Diest AM, Hershey AD, Powers SW. Trajectory of Improvement in Children and Adolescents With Chronic Migraine: Results From the Cognitive-Behavioral Therapy and Amitriptyline Trial. J Pain. 2017 Jun;18(6):637-644. doi: 10.1016/j.jpain.2017.01.002. Epub 2017 Jan 18.
PubMed 28108386Kroner JW, Hershey AD, Kashikar-Zuck SM, LeCates SL, Allen JR, Slater SK, Zafar M, Kabbouche MA, O'Brien HL, Shenk CE, Rausch JR, Kroon Van Diest AM, Powers SW. Cognitive Behavioral Therapy plus Amitriptyline for Children and Adolescents with Chronic Migraine Reduces Headache Days to </=4 Per Month. Headache. 2016 Apr;56(4):711-6. doi: 10.1111/head.12795. Epub 2016 Mar 18.
PubMed 26992129Powers SW, Kashikar-Zuck SM, Allen JR, LeCates SL, Slater SK, Zafar M, Kabbouche MA, O'Brien HL, Shenk CE, Rausch JR, Hershey AD. Cognitive behavioral therapy plus amitriptyline for chronic migraine in children and adolescents: a randomized clinical trial. JAMA. 2013 Dec 25;310(24):2622-30. doi: 10.1001/jama.2013.282533.
PubMed 24368463Zafar M, Kashikar-Zuck SM, Slater SK, Allen JR, Barnett KA, Lecates SL, Kabbouche MA, Hershey AD, Powers SW. Childhood abuse in pediatric patients with chronic daily headache. Clin Pediatr (Phila). 2012 Jun;51(6):590-3. doi: 10.1177/0009922811407181. Epub 2011 May 18. No abstract available.
PubMed 21593054
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug and Non-Drug Treatment of Pediatric Chronic Headache
- ClinicalTrials.gov ID
- NCT00389038
- Acronym / sponsor ID
- R01NS050536
- Conditions
- Headache
- Keywords
- headache, coping skills training, amitriptyline, attention control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Oct 2006
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 17 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coping Skills Training + Amitriptyline | Active comparator | Behavioral: Coping Skills Training, Drug: AmitriptylineBehavioral 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 + Amitriptyline | Active comparator | Behavioral: Headache Education, Drug: AmitriptylineBehavioral headache education |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping Skills TrainingBehavioral 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. | Behavioural | Coping Skills Training + Amitriptyline |
| Headache EducationBehavioral Treatment 2 (headache education) | Behavioural | Headache Education + Amitriptyline |
| AmitriptylineAmitriptyline: 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. | Drug | Coping Skills Training + Amitriptyline, Headache Education + Amitriptyline |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2011.
- Derived from this study: PubMed 34028656Rettig EK, Ergun G, Warfield JR, Slater SK, LeCates SL, Kabbouche MA, Kacperski J, Hershey AD, Powers SW. Predictors of Improvement in Pediatric Chronic Migraine: Results from the Cognitive-Behavioral Therapy and Amitriptyline Trial. J Clin Psychol Med Settings. 2022 Mar;29(1):113-119. doi: 10.1007/s10880-021-09782-4. Epub 2021 May 24.
- Derived from this study: PubMed 28108386Kroner JW, Peugh J, Kashikar-Zuck SM, LeCates SL, Allen JR, Slater SK, Zafar M, Kabbouche MA, O'Brien HL, Shenk CE, Kroon Van Diest AM, Hershey AD, Powers SW. Trajectory of Improvement in Children and Adolescents With Chronic Migraine: Results From the Cognitive-Behavioral Therapy and Amitriptyline Trial. J Pain. 2017 Jun;18(6):637-644. doi: 10.1016/j.jpain.2017.01.002. Epub 2017 Jan 18.
- Derived from this study: PubMed 26992129Kroner JW, Hershey AD, Kashikar-Zuck SM, LeCates SL, Allen JR, Slater SK, Zafar M, Kabbouche MA, O'Brien HL, Shenk CE, Rausch JR, Kroon Van Diest AM, Powers SW. Cognitive Behavioral Therapy plus Amitriptyline for Children and Adolescents with Chronic Migraine Reduces Headache Days to </=4 Per Month. Headache. 2016 Apr;56(4):711-6. doi: 10.1111/head.12795. Epub 2016 Mar 18.
- Derived from this study: PubMed 24368463Powers SW, Kashikar-Zuck SM, Allen JR, LeCates SL, Slater SK, Zafar M, Kabbouche MA, O'Brien HL, Shenk CE, Rausch JR, Hershey AD. Cognitive behavioral therapy plus amitriptyline for chronic migraine in children and adolescents: a randomized clinical trial. JAMA. 2013 Dec 25;310(24):2622-30. doi: 10.1001/jama.2013.282533.
- Derived from this study: PubMed 21593054Zafar M, Kashikar-Zuck SM, Slater SK, Allen JR, Barnett KA, Lecates SL, Kabbouche MA, Hershey AD, Powers SW. Childhood abuse in pediatric patients with chronic daily headache. Clin Pediatr (Phila). 2012 Jun;51(6):590-3. doi: 10.1177/0009922811407181. Epub 2011 May 18. No abstract available.
- Cincinnati Children's Hospital Lab Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott W. Powers, PhD, ABPP, FAHS principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coping Skills Training, Headache Education and Amitriptyline in people with Headache, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00389038, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2011.