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Corticosteroid
CBT + Amitriptyline for Childhood Migraine
N/A
Recruiting
Led By Scott Powers, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis: Migraine with or without aura that meets the International Classification of Headache Disorders (ICHD) criteria 5 or presentation of continuous headache that includes migranous episodes based upon headache history obtained by site PI or designee (includes presentation with or without medication overuse headache as well)
Be younger than 18 years old
Must not have
Report of current or ongoing suicidal thoughts. Suicide attempt within the past six months. History of bipolar disorder, prolonged QT, or pre-existing significant constipation or gastroparesis
Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 4-8 to weeks 20-24 (post treatment)
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare Cognitive Behavioral Therapy (CBT) via telehealth with a pill-based preventive therapy (amitriptyline) for treating childhood migraine. Results will help provide evidence-based, accessible care.
Who is the study for?
This trial is for young people who have migraines at least 4 days a month and meet specific migraine criteria. They must be able to speak English, not be pregnant, and can't currently be on certain migraine medications like Botox or CGRP antibodies. They also shouldn't have taken amitriptyline or had CBT for headaches recently, nor should they have serious mental health issues.
What is being tested?
The study tests if Cognitive Behavioral Therapy (CBT) via telehealth combined with the medication amitriptyline is more effective than just CBT via telehealth in preventing migraines in youth. Participants will either receive both treatments or only CBT to see which works better.
What are the potential side effects?
Amitriptyline may cause dry mouth, drowsiness, constipation, blurred vision and weight gain. CBT generally has no side effects but discussing distressing topics during therapy sessions might temporarily increase anxiety or emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with migraines, following international headache guidelines.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had suicidal thoughts, attempts, bipolar disorder, heart rhythm issues, or severe constipation.
Select...
I am currently using Botox or CGRP antibodies for migraine prevention.
Select...
I am a young person and I am pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to weeks 4-8 to weeks 20-24 (post treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 4-8 to weeks 20-24 (post treatment)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in number of headache days
Reduction to a PedMIDAS score of 20 or less
Secondary study objectives
Change in absolute headache days
Change in absolute headache disability score on PedMIDAS
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline)Experimental Treatment2 Interventions
This intervention consists of Cognitive Behavioral (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements. This arm will also take a daily oral dose of Amitriptyline, which will be clinically prescribed and managed by the patient's headache provider.
Group II: CBT aloneExperimental Treatment1 Intervention
This intervention arm consists of 6 Cognitive Behavioral Therapy (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amitriptyline
2008
Completed Phase 4
~1710
CBT
2013
Completed Phase 3
~4220
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,203 Total Patients Enrolled
6 Trials studying Migraine
1,903 Patients Enrolled for Migraine
Patient-Centered Outcomes Research InstituteOTHER
579 Previous Clinical Trials
27,091,919 Total Patients Enrolled
1 Trials studying Migraine
720 Patients Enrolled for Migraine
Scott Powers, PhDPrincipal InvestigatorCincinnati Childrens Medical Center, Cincinnati
3 Previous Clinical Trials
575 Total Patients Enrolled
3 Trials studying Migraine
575 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated with amitriptyline or undergoing cognitive behavioral therapy for headaches.I am currently taking medication to prevent migraines.I am approved to take amitriptyline for preventing migraines.I have not had suicidal thoughts, attempts, bipolar disorder, heart rhythm issues, or severe constipation.I've had 4 or more headache days in the last 28 days.I am currently using Botox or CGRP antibodies for migraine prevention.I have been diagnosed with migraines, following international headache guidelines.I am a young person and I am pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline)
- Group 2: CBT alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.