Are clinical trials safe?

Yes. Every study on QualifiedStudies is reviewed and approved by an Institutional Review Board (IRB) and conducted under FDA regulations. Research sites are HIPAA-covered entities, and you can withdraw at any time for any reason.

Do I get paid to participate in a clinical trial?

Most studies offer compensation for your time and travel. The amount varies by study length and visit schedule, and is disclosed up front before you enroll.

Is my health information kept private?

Yes. Your information is encrypted, never sold, and only shared with the specific research site you choose to apply to. Our handling of your data is governed by our Consumer Health Data Privacy Policy; the research sites you're matched with are HIPAA-covered entities.

How do I qualify for a clinical trial?

Take our free 60-second eligibility quiz. Enter your ZIP code, condition, and a few health details, and we'll match you with research sites near you that are actively enrolling participants.

Responding With Evidence and Access for Childhood Headaches

NCT ID: NCT05889624
Registry status: Recruiting
Study type: Interventional
Phase: Not applicable
Sponsor: Children's Hospital Medical Center, Cincinnati
Conditions: Chronic Migraine, Headache, Headache Disorders, Headache, Migraine, Migraine, Migraine Disorders, Migraine With Aura, Migraine Without Aura

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)

Enrollment: 400 participants (Estimated).

What is being studied

Intervention: Amitriptyline
Drug: Amitriptyline
Intervention: Behavior Therapy
Intervention: Behavioral Disciplines and Activities
Intervention: Benzocycloheptenes
Behavioral: CBT
Intervention: Cognitive Behavioral Therapy
Intervention: Dibenzocycloheptenes
Intervention: Hydrocarbons
Intervention: Hydrocarbons, Aromatic
Intervention: Hydrocarbons, Cyclic
Intervention: Organic Chemicals
Intervention: Polycyclic Aromatic Hydrocarbons
Intervention: Polycyclic Compounds
Intervention: Psychotherapy

Who may be eligible

Ages: 10 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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) * Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization * Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive treatment for migraine * English fluency: Able to complete the study visits and questionnaires in English Exclusion Criteria: * Current treatment includes amitriptyline and/or CBT specific to headache care * Current prescribed preventive antimigraine medication within a period equivalent to \< 5 half-lives of that medication before entering the baseline phase * Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention * Youth who are pregnant * 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 * Any and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the participant

Study locations

15 study locations are listed.

Recruiting site status is explicitly provided for 15 locations; 15 are listed as Recruiting.

Countries: United States

Alabama, United States: 1
Arizona, United States: 1
California, United States: 1
Colorado, United States: 1
Delaware, United States: 1
Georgia, United States: 1
Kentucky, United States: 1
Louisiana, United States: 1
New York, United States: 1
Ohio, United States: 2
Pennsylvania, United States: 1
Tennessee, United States: 1
Texas, United States: 1
West Virginia, United States: 1

Sample of listed locations

University of Alabama at Birmingham Children's of Alabama — Birmingham, Alabama, 35233, United States — Recruiting
Phoenix Children's Hospital - Barrow Neurological Institute — Phoenix, Arizona, 85016-7710, United States — Recruiting
University of California San Francisco — San Francisco, California, 94115, United States — Recruiting
University of Colorado/Children's Hospital Colorado — Aurora, Colorado, 80045, United States — Recruiting
Nemours Children's Health System — Wilmington, Delaware, 19810, United States — Recruiting
Clinical Integrative Research Center of Atlanta, Inc — Atlanta, Georgia, 30328, United States — Recruiting
Norton Children's Neuroscience Institute/ UofL School of Medicine — Louisville, Kentucky, 40292, United States — Recruiting
Louisiana State Univ/Children's Hospital of New Orleans — New Orleans, Louisiana, 70118-5720, United States — Recruiting
Dent Neurological Institute — Amherst, New York, 14226, United States — Recruiting
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, 45229, United States — Recruiting
Nationwide Childrens — Columbus, Ohio, 43205, United States — Recruiting
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, 19104, United States — Recruiting
University of Tennessee Health Science Center/ LeBonheur Children's Hospital — Memphis, Tennessee, 38103, United States — Recruiting
Dell Children's Hospital-UT Health — Austin, Texas, 78712, United States — Recruiting
Marshall Health — Huntington, West Virginia, 25701, United States — Recruiting

Study details

Start date: August 22, 2023
Primary completion date: July 31, 2027
Completion date: December 31, 2027
First posted: June 5, 2023
Collaborators: Patient-Centered Outcomes Research Institute

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05889624
Registry last updated: September 21, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT05889624 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Chronic Pain studies | Migraines studies | Clinical trial FAQ