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Oral MS drug shows promise for kids in landmark trial

NCT ID NCT02283853

Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 3 trial tested the oral drug dimethyl fumarate (Tecfidera) against an injected interferon in 156 children aged 10 to 17 with relapsing-remitting multiple sclerosis. The main goal was to see if the drug could prevent new brain lesions and control the disease safely. The study also looked at long-term safety in an optional extension phase.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dimethyl fumarate (Tecfidera)
What this could lead to
If successful, this could provide a safe and effective oral treatment option for children with relapsing-remitting multiple sclerosis, reducing brain lesions and slowing disability.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all children. Side effects like flushing and stomach issues are common with dimethyl fumarate, and long-term safety data are still limited.

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

156 people

The number who actually took part.

Started

Aug 2014

Finished

Jul 2025

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.

Key Inclusion Criteria: * Males and females aged from 10 to less than 18 years old at the time of informed consent or assent. * Must have a body weight of ≥30 kg. * Must have a diagnosis of RRMS (consensus definition for pediatric RRMS \[Krupp 2013\]). * Must be ambulatory with a baseline EDSS score between 0 and 5.5, inclusive. * Must have experienced at least 1 of the following 3 conditions: a) at least 1 relapse within the last 12 months prior to Day 1 with a prior brain MRI demonstrating lesions consistent with MS; b) at least 2 relapses within the last 24 months prior to Day 1, with a prior brain MRI demonstrating lesions consistent with MS; c) evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to Day 1. * Must be neurologically stable, with no evidence of relapse within 50 days prior to Day 1 and no evidence of corticosteroid treatment within 30 days prior to Day 1. * Participants of childbearing potential who are sexually active must be willing to practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their final dose of study treatment. Key Exclusion Criteria: * Primary progressive, secondary progressive, or progressive relapsing MS (as defined by \[Lublin and Reingold 1996\]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Participants with these conditions may also have superimposed relapses but are distinguished from relapsing-remitting participants by the lack of clinically stable periods or clinical improvement. * Disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease, lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders. * History of premalignant or malignant disease. Participants with basal cell carcinoma that has been completely excised prior to screening will remain eligible. * History of severe allergic or anaphylactic reactions, or known drug hypersensitivity to DMF, fumaric acid esters, or interferon beta-1a (IFN Beta-1a). * History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or any other major disease that would preclude participation in a clinical study. * History of clinically significant cardiovascular, pulmonary, GI, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease that would preclude participation in a clinical study. * History of human immunodeficiency virus. * An MS relapse that has occurred within 50 days prior to Day 1 AND/OR the participant has not stabilized from a previous relapse prior to Day 1. * Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the participant unsuitable for enrollment. NOTE: Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Relapsing-remitting multiple sclerosis

Contacts and locations

Locations

  • Akdeniz University Faculty of Medicine

    Antalya, 07070, Turkey (Türkiye)

  • Azienda Ospedale-Università di Padova

    Padova, 35128, Italy

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189, Italy

  • Azienda Ospedaliera Universitaria 'Federico II'

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, 70124, Italy

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127, Italy

  • Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)

    Gallarate, Varese, 21013, Italy

  • Birmingham Children's Hospital

    Birmingham, West Midlands, B4 6NH, United Kingdom

  • Boston Children's Hospital

    Boston, Massachusetts, 2115, United States

  • CHU Amiens - Hopital Sud

    Amiens, Somme, 80054, France

  • CHU Clermont Ferrand - Hôpital d'Estaing

    Clermont-Ferrand, Puy De Dome, 63003, France

  • CHU Dijon -BOCAGE CENTRAL

    Dijon, Côte-d'Or, 21079, France

  • CHU Rennes - Hopital Pontchaillou

    Rennes, Ille Et Vilaine, 35033, France

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, Bas Rhin, 67098, France

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • Clinic of Neurology and Psychiatry for Children and Youth

    Belgrade, 11000, Serbia

  • Evelina London Children's Hospital

    London, Greater London, SE1 7EH, United Kingdom

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52, Czechia

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91, Czechia

  • Great Ormond Street Hospital for Children

    London, Greater London, WC1N 3JH, United Kingdom

  • Hacettepe University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 91120, Israel

  • Heim Pal Orszagos Gyermekgyogyaszati Intezet

    Budapest, 1089, Hungary

  • Hopital Gui de Chauliac

    Montpellier, Herault, 34295, France

  • Hopital Neurologique Pierre Wertheimer

    Bron, Rhone, 69677, France

  • Hopital Roger Salengro - CHU Lille

    Lille, Nord, 59037, France

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, Barcelona, 8950, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14011, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, Madrid, 28850, Spain

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, Val De Marne, 94275, France

  • Hôpital de Brabois Enfants

    Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54500, France

  • Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385, France

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Ibn Sina Hospital

    Ash Shuwaykh, 12345, Kuwait

  • Instytut 'Pomnik - Centrum Zdrowia Dziecka'

    Warsaw, 04-730, Poland

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Karolinska

    Stockholm, SE-113 61, Sweden

  • Katholisches Klinikum Bochum gGmbH

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Klinikum der Universitaet Muenchen

    Munich, Bavaria, 80337, Germany

  • MHATNP 'Sv.Naum', EAD

    Sofia, 1113, Bulgaria

  • Mother and Child Health Care Institute of Serbia ,,Dr Vukan Cupic''

    Belgrade, 11000, Serbia

  • Nemocnice Jihlava p.o.

    Jihlava, 58633, Czechia

  • Odense Universitetshospital

    Odense, 5000, Denmark

  • Ospedale Pediatrico Bambino Gesù

    Roma, 00165, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • SPZOZ Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

    Bialystok, 15-274, Poland

  • Sahlgrenska Sjukhuset

    Gothenburg, 41345, Sweden

  • Schneider Children's Medical Center

    Petah Tikva, 4920235, Israel

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu

    Poznan, 60-355, Poland

  • The National Hospital for Neurology & Neurosurgery

    London, Greater London, WC1N 3BG, United Kingdom

  • The Rector and Visitors of the University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Universitaetsklinikum Augsburg

    Augsburg, Bavaria, 86156, Germany

  • Universitair Kinderziekenhuis Koningin Fabiola

    Brussels, 1020, Belgium

  • Universitair Ziekenhuis Ghent

    Ghent, 9000, Belgium

  • University Clinical Center Kragujevac

    Kragujevac, 34000, Serbia

  • University of Calgary - Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8, Canada

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-211, Poland

  • Århus Universitetshospital

    Aarhus N, 8200, Denmark

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