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Online therapy plus pill may cut Kids' migraines in half

NCT ID NCT05889624

Prevention Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests whether adding a daily pill (amitriptyline) to online cognitive behavioral therapy (CBT) helps prevent migraines in children better than online therapy alone. About 400 kids with frequent migraines will be followed for months to see if headache days drop by half and daily life improves. The goal is to find the best first-line treatment that is easy to access from home.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Headache headache disorder migraine disorder migraine with aura migraine without aura

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic migraine Headache Headache disorders Headache, migraine Migraine Migraine disorders Migraine with aura Migraine without aura

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

    Contact Email: •••••@•••••

  • Clinical Integrative Research Center of Atlanta, Inc

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Dell Children's Hospital-UT Health

    RECRUITING

    Austin, Texas, 78712, United States

  • Dent Neurological Institute

    RECRUITING

    Amherst, New York, 14226, United States

  • Louisiana State Univ/Children's Hospital of New Orleans

    RECRUITING

    New Orleans, Louisiana, 70118-5720, United States

  • Marshall Health

    RECRUITING

    Huntington, West Virginia, 25701, United States

  • Nationwide Childrens

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Nemours Children's Health System

    RECRUITING

    Wilmington, Delaware, 19810, United States

  • Norton Children's Neuroscience Institute/ UofL School of Medicine

    RECRUITING

    Louisville, Kentucky, 40292, United States

  • Phoenix Children's Hospital - Barrow Neurological Institute

    RECRUITING

    Phoenix, Arizona, 85016-7710, United States

  • University of Alabama at Birmingham Children's of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94115, United States

  • University of Colorado/Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Tennessee Health Science Center/ LeBonheur Children's Hospital

    RECRUITING

    Memphis, Tennessee, 38103, United States

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