NCT05889624 Responding With Evidence and Access for Childhood Headaches
| NCT ID | NCT05889624 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Headache |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-08-22 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2023-08-22 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Scott Powers, PhD
PRINCIPAL INVESTIGATOR
Cincinnati Childrens Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT05889624 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 17 Years, studying Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05889624 currently recruiting?
Yes, NCT05889624 is actively recruiting participants. Contact the research team at leighann.chamberlin@cchmc.org for enrollment information.
Where is the NCT05889624 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, San Francisco, United States, Aurora, United States and 11 additional locations.
Who is sponsoring the NCT05889624 clinical trial?
NCT05889624 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Scott Powers, PhD at Cincinnati Childrens Medical Center, Cincinnati. The trial plans to enroll 400 participants.