Responding With Evidence and Access for Childhood Headaches

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · May 22, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Responding With Evidence and Access for Childhood Headaches," is investigating the best ways to prevent migraines in children and teenagers. Researchers want to see if combining a type of therapy called Cognitive Behavioral Therapy (CBT) delivered through telehealth (online) with a medication called amitriptyline is more effective than using CBT alone. The goal is to find effective treatments that are accessible and based on solid evidence, helping healthcare providers make better choices for their young patients suffering from headaches.

To participate, young people aged between 10 to 17 who have been diagnosed with migraines (with or without accompanying symptoms) and experience at least four headache days a month may be eligible. Participants must be able to understand and complete study materials in English and should not be currently receiving certain migraine treatments, including amitriptyline or specific therapies for headache care. If eligible, participants will receive either the combined treatment of CBT and medication or just CBT through telehealth sessions. This study aims to provide valuable insights into effective headache management for children and teens.

Gender

ALL

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