Responding With Evidence and Access for Childhood Headaches
Recruiting · NCT05889624 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital Medical Center, Cincinnati
View the official record on ClinicalTrials.gov →Interventions studied
AmitriptylineCBT
What this trial is about
This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.
Who can take part
Age range
10 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
15 locations listed across 14 US states.
- University of Alabama at Birmingham Children's of Alabama - Birmingham, Alabama, United States
- Phoenix Children's Hospital - Barrow Neurological Institute - Phoenix, Arizona, United States
- University of California San Francisco - San Francisco, California, United States
- University of Colorado/Children's Hospital Colorado - Aurora, Colorado, United States
- Nemours Children's Health System - Wilmington, Delaware, United States
- Clinical Integrative Research Center of Atlanta, Inc - Atlanta, Georgia, United States
- Norton Children's Neuroscience Institute/ UofL School of Medicine - Louisville, Kentucky, United States
- Louisiana State Univ/Children's Hospital of New Orleans - New Orleans, Louisiana, United States
- Dent Neurological Institute - Amherst, New York, United States
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States
- Nationwide Childrens - Columbus, Ohio, United States
- Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States
- University of Tennessee Health Science Center/ LeBonheur Children's Hospital - Memphis, Tennessee, United States
- Dell Children's Hospital-UT Health - Austin, Texas, United States
- Marshall Health - Huntington, West Virginia, United States