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New hope for kids with MS: Head-to-Head drug trial launches

NCT ID NCT06408259

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 2 times

Summary

This study compares two daily pills, ozanimod and fingolimod, to see which works better at preventing MS relapses in children and teens aged 10 to 17. Participants will be randomly assigned to one of the two drugs and monitored for about two years. The goal is to find a more effective and safer option for managing this chronic condition.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 194 people

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

Started

Apr 2025

Expected to finish

Jul 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease. * Meets at least 1 of the following criteria for disease activity: i) At least 1 MS relapse/attack in the previous year prior to screening. ii) At least 2 MS relapses/attacks in the previous 2 years prior to screening. iii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI). \- Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive. Exclusion Criteria: * Diagnosis of progressive forms of MS. * Active or chronic disease of the immune system other than MS. * Clinically relevant cardiovascular, hepatic, neurological other major systematic disease. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    27 sites in 9 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • 2Ca Braga

    RECRUITING

    Braga, 4710-243, Portugal

  • CHUVI- Hospital Alvaro Cunqueiro

    RECRUITING

    Vigo, Pontevedra [Pontevedra], 36203, Spain

  • Centro Hospitalar de Lisboa Central

    RECRUITING

    Lisbon, 1169-050, Portugal

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Local Institution - 0078

    WITHDRAWN

    Mexico City, DIF, 04530, Mexico

  • Local Institution - 0081

    NOT_YET_RECRUITING

    Milan, Lombardy, 20133, Italy

  • Local Institution - 0091

    WITHDRAWN

    Cincinnati, Ohio, 45229, United States

  • Local Institution - 0092

    NOT_YET_RECRUITING

    Portland, Oregon, 97225, United States

  • Local Institution - 0093

    WITHDRAWN

    Chicago, Illinois, 60611, United States

  • Local Institution - 0096

    NOT_YET_RECRUITING

    Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

  • Local Institution - 0102

    WITHDRAWN

    Porto, 4200-319, Portugal

  • Local Institution - 0108

    COMPLETED

    Poznan, Greater Poland Voivodeship, 60-355, Poland

  • Local Institution - 0114

    NOT_YET_RECRUITING

    Loma Linda, California, 92354, United States

  • Local Institution - 0131

    NOT_YET_RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Local Institution - 0132

    WITHDRAWN

    Teaneck, New Jersey, 07666, United States

  • Local Institution - 0133

    NOT_YET_RECRUITING

    El Paso, Texas, 79912, United States

  • Local Institution - 0134

    NOT_YET_RECRUITING

    Caguas, 00725, Puerto Rico

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • Neurological Center Of Latium

    RECRUITING

    Rome, Roma, 00178, Italy

  • Ondokuz Mayıs Universitesi

    RECRUITING

    Samsun, 55270, Turkey (Türkiye)

  • Ospedale San Raffaele

    RECRUITING

    Milan, Lombardy, 20132, Italy

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital

    RECRUITING

    Bucharest, Bucharest, 041914, Romania

  • Royal Children's Hospital

    RECRUITING

    Melbourne, Victoria, 3052, Australia

  • Spitalul Clinic de Copii Doctor Victor Gomoiu

    RECRUITING

    Bucharest, Bucharest, 022102, Romania

  • Unidade Local de Saúde de Coimbra, E.P.E.

    RECRUITING

    Coimbra, 3000-602, Portugal

  • University of California Davis Health

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Louisville, Norton Children's Research Institute

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Naples Federico II

    RECRUITING

    Naples, Campania, 80131, Italy

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.