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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 4-8 to weeks 20-24 (post treatment)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with migraines, following international headache guidelines.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in number of headache days

Reduction to a PedMIDAS score of 20 or less

Secondary outcome measures

Change in absolute headache days

Change in absolute headache disability score on PedMIDAS

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

CBT

2013

Completed Phase 3

~4220

Amitriptyline

2008

Completed Phase 4

~1710

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,191 Total Patients Enrolled

6 Trials studying Migraine

1,903 Patients Enrolled for Migraine

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,997,058 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

Amitriptyline (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05889624 — N/A

Migraine Research Study Groups: CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline), CBT alone

Migraine Clinical Trial 2023: Amitriptyline Highlights & Side Effects. Trial Name: NCT05889624 — N/A

Amitriptyline (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05889624 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criterion for this experiment encompass participants under 20 years of age?

"Patient inclusion criteria state that those between the ages of 10 to 17 are welcome to partake in this study."

Answered by AI

Could I be a participant in this research study?

"The criterion for recruitment into this study necessitates that participants have a diagnosis of migraine and are between 10 to 17 years old. In total, 400 individuals must be accepted to join the research program."

Answered by AI

How many venues are currently offering participation in this research?

"Currently, 14 different locations around the country are admitting patients into this trial; some of them being Phoenix, San Francisco and Aurora. To minimise travelling demands, it is suggested to pick a clinic in proximity."

Answered by AI

Is there any capacity for new participants in this experiment?

"The information available on clinicaltrials.gov suggests that this study is not currently recruiting participants, as the trial was most recently updated in May of 2023. Nevertheless, there are 1250 other trials actively seeking patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Responding With Evidence and Access for Childhood Headaches

2023. "Responding With Evidence and Access for Childhood Headaches". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05889624.

All > Chronic Daily Headache > Migraine