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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 below

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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:

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I have not had suicidal thoughts, attempts, bipolar disorder, heart rhythm issues, or severe constipation.

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I am currently using Botox or CGRP antibodies for migraine prevention.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 4-8 to weeks 20-24 (post treatment) for reporting.

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