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NCT05889624 · ClinicalTrials.gov registry record · NA

Responding With Evidence and Access for Childhood Headaches

A NA study of Migraine and Headache, sponsored by Children's Hospital Medical Center, Cincinnati.

Recruiting
Registry status
NA
Development phase
400
Enrollment target
15
Study locations

NCT05889624: Recruiting NA study of Migraine and Headache, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT05889624 is a NA study of Migraine and Headache that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 400 participants, above the 354-participant average among 102 other Migraine trials with a reported enrollment target (13% higher). The trial reports 15 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05889624, a NA study of Migraine and Headache, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.

RECRUITING
Registry status
NA
Development phase
400 participants
Enrollment target
15
Study locations

Study 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.

Primary Outcome

This outcome measures whether there is a 50% reduction in the number of headaches days based on a self reported daily headache diary, per 28-day period, between the two arms.

Conditions Studied

Migraine Headache Migraine Disorders Chronic Migraine Headache, Migraine Migraine With Aura Migraine Without Aura Headache Disorders

Interventions

  • BEHAVIORAL CBT
  • DRUG Amitriptyline

Study Locations (15)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati
  • Nationwide Childrens - Columbus

Alabama

  • University of Alabama at Birmingham Children's of Alabama - Birmingham

Arizona

  • Phoenix Children's Hospital - Barrow Neurological Institute - Phoenix

California

  • University of California San Francisco - San Francisco

Colorado

  • University of Colorado/Children's Hospital Colorado - Aurora

Delaware

  • Nemours Children's Health System - Wilmington

Georgia

  • Clinical Integrative Research Center of Atlanta, Inc - Atlanta

Kentucky

  • University of Louisville Health/Norton - Louisville

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2023-08-22
Est. Completion 2027-12-31
Phase NA
Children's Hospital Medical Center, Cincinnati

571 total trials

What NCT05889624 shows while recruiting

NCT05889624 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 354-participant average among 102 other Migraine trials with a reported enrollment target (13% higher).

The record links to 8 conditions, with Migraine appearing as the primary indexed condition, and to 2 interventions - of which CBT is the first listed.

NCT05889624 lists 15 locations in 14 states (Ohio, Alabama, Arizona).

Frequently Asked Questions

What is clinical trial NCT05889624 about?

NCT05889624 is a clinical study titled "Responding With Evidence and Access for Childhood Headaches". 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 you...

What is the current status of trial NCT05889624?

This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2023-08-22. Estimated completion is 2027-12-31.

What conditions does trial NCT05889624 study?

This clinical trial studies the following conditions: Migraine, Headache, Migraine Disorders, Chronic Migraine, Headache, Migraine.

What interventions are being tested in trial NCT05889624?

The interventions under investigation include: CBT (BEHAVIORAL), Amitriptyline (DRUG).

Who is sponsoring clinical trial NCT05889624?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05889624 being conducted?

This trial has 15 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Migraine

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05889624's enrollment target sits among peer trials

400 28th of 102 higher than 75 of 102 other Migraine trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05889624

Source: ClinicalTrials.gov NCT05889624, the US trial registry maintained by the National Library of Medicine. NCT05889624 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.