New hope for kids with MS: Head-to-Head drug trial launches
NCT ID NCT06408259
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 194 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jul 2036
An estimate. End dates often move.
- Lead sponsor
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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
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10 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
27 sites in 9 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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2Ca Braga
RECRUITINGBraga, 4710-243, Portugal
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CHUVI- Hospital Alvaro Cunqueiro
RECRUITINGVigo, Pontevedra [Pontevedra], 36203, Spain
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Centro Hospitalar de Lisboa Central
RECRUITINGLisbon, 1169-050, Portugal
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Hospital Universitari i Politecnic La Fe
RECRUITINGValencia, 46026, Spain
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Hospital Universitario Miguel Servet
RECRUITINGZaragoza, 50009, Spain
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Hospital Universitario Virgen Macarena
RECRUITINGSeville, 41009, Spain
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Local Institution - 0078
WITHDRAWNMexico City, DIF, 04530, Mexico
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Local Institution - 0081
NOT_YET_RECRUITINGMilan, Lombardy, 20133, Italy
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Local Institution - 0091
WITHDRAWNCincinnati, Ohio, 45229, United States
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Local Institution - 0092
NOT_YET_RECRUITINGPortland, Oregon, 97225, United States
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Local Institution - 0093
WITHDRAWNChicago, Illinois, 60611, United States
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Local Institution - 0096
NOT_YET_RECRUITINGEsplugues de Llobregat, Barcelona [Barcelona], 08950, Spain
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Local Institution - 0102
WITHDRAWNPorto, 4200-319, Portugal
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Local Institution - 0108
COMPLETEDPoznan, Greater Poland Voivodeship, 60-355, Poland
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Local Institution - 0114
NOT_YET_RECRUITINGLoma Linda, California, 92354, United States
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Local Institution - 0131
NOT_YET_RECRUITINGNew Brunswick, New Jersey, 08901, United States
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Local Institution - 0132
WITHDRAWNTeaneck, New Jersey, 07666, United States
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Local Institution - 0133
NOT_YET_RECRUITINGEl Paso, Texas, 79912, United States
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Local Institution - 0134
NOT_YET_RECRUITINGCaguas, 00725, Puerto Rico
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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National Taiwan University Hospital
RECRUITINGTaipei, 10002, Taiwan
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Neurological Center Of Latium
RECRUITINGRome, Roma, 00178, Italy
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Ondokuz Mayıs Universitesi
RECRUITINGSamsun, 55270, Turkey (Türkiye)
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Ospedale San Raffaele
RECRUITINGMilan, Lombardy, 20132, Italy
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Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITINGBucharest, Bucharest, 041914, Romania
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Royal Children's Hospital
RECRUITINGMelbourne, Victoria, 3052, Australia
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Spitalul Clinic de Copii Doctor Victor Gomoiu
RECRUITINGBucharest, Bucharest, 022102, Romania
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Unidade Local de Saúde de Coimbra, E.P.E.
RECRUITINGCoimbra, 3000-602, Portugal
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University of California Davis Health
RECRUITINGSacramento, California, 95817, United States
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University of Chicago Medical Center
RECRUITINGChicago, Illinois, 60637, United States
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University of Louisville, Norton Children's Research Institute
RECRUITINGLouisville, Kentucky, 40202, United States
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University of Naples Federico II
RECRUITINGNaples, Campania, 80131, Italy
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University of South Florida
RECRUITINGTampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can diet ease the crushing fatigue of multiple sclerosis?
- Which MS treatment strategy preserves the brain better?
- Can a gentle electric zap to the brain restore memory in MS?
- Brain scans may reveal how MS drug affects mental fatigue
- Brain scans could reveal which MS drugs fight mental exhaustion
- Brain shrinkage as a crystal ball for MS progression?