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Daily pill may beat weekly shot for kids with MS

NCT ID NCT01892722

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study tests whether a daily fingolimod capsule works better than a weekly interferon injection to prevent multiple sclerosis relapses in children. About 240 kids with MS will take one of the two treatments for 2 years, followed by a 5-year extension where everyone gets fingolimod. The main goal is to see which drug reduces relapse rates more effectively.

What this could mean

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

Active substance
fingolimod (taken daily as a capsule) and interferon beta-1a (given as a weekly injection)
What this could lead to
If fingolimod works better than interferon, it could become a preferred treatment to reduce relapses in children with multiple sclerosis.
What could go wrong
This is a phase 3 trial, but results may not apply to all children. Fingolimod has known risks like heart issues and infections, and it requires lifelong medication to manage the disease, not cure it.

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

240 people

The number who actually took part.

Started

Jul 2013

Expected to finish

Feb 2030

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.

Key Inclusion Criteria Core Phase: * diagnosis of multiple sclerosis * at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive Key Exclusion Criteria Core Phase: * patients with progressive MS * patients with an active, chronic disease of the immune system other than MS * patients meeting the definition of ADEM * patients with severe cardiac disease or significant findings on the screening ECG. * patients with severe renal insufficiency Key Inclusion Criteria Extension Phase: Applies to all patients participating in the Core Phase and then entering the Extension Phase. 1. Patients that originally met Core Phase Inclusion criteria and completed the Core phase on or off of study drug. Applies to patients newly recruited to participate in the Extension Phase. * All newly recruited patients' that enroll directly into the Extension Phase must fulfill the local country health authority product label approved for pediatric age group for inclusion criteria. * Central review (including initial MRI report) of the diagnosis of pediatric MS will be required for all newly recruited patients. Key Exclusion Criteria Extension Phase: Applies to patients who completed the Core Phase, but prematurely discontinued study drug. 1. Premature discontinuation of the study drug during the Core Phase due to: * an adverse event, * serious adverse event, * laboratory abnormality * other conditions leading to permanent study drug discontinuation due to safety reasons 2. Patients with known new events or concomitant medications (washout periods required prior to Visit 15) that would exclude them from the Core Phase exclusion criteria. Serological or other additional tests will not be required. Applies to patients newly recruited in the younger cohort to participate in the Extension Phase. 1\. All newly recruited patients in the younger cohort that enroll directly into the Extension Phase must fulfill the exclusion criteria for the core phase.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis Thinness

As listed by the trial registrant

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

Multiple sclerosis

Contacts and locations

Locations

  • AMO Corporation

    Tallahassee, Florida, 32312, United States

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-4399, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Novartis Investigative Site

    Parkville, Victoria, 3052, Australia

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20270-004, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000, Brazil

  • Novartis Investigative Site

    Goiânia, 74605-020, Brazil

  • Novartis Investigative Site

    Sofia, 1113, Bulgaria

  • Novartis Investigative Site

    Calgary, Alberta, T3B 6A8, Canada

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6, Canada

  • Novartis Investigative Site

    Osijek, 31000, Croatia

  • Novartis Investigative Site

    Tallinn, 10617, Estonia

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275, France

  • Novartis Investigative Site

    Marseille, 13885, France

  • Novartis Investigative Site

    Montpellier, 34090, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Bochum, 44791, Germany

  • Novartis Investigative Site

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    Bari, BA, 70124, Italy

  • Novartis Investigative Site

    Montichiari, BS, 25018, Italy

  • Novartis Investigative Site

    Catania, CT, 95123, Italy

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Cefalù, PA, 90015, Italy

  • Novartis Investigative Site

    Roma, RM, 00133, Italy

  • Novartis Investigative Site

    Roma, RM, 00189, Italy

  • Novartis Investigative Site

    Gallarate, VA, 21013, Italy

  • Novartis Investigative Site

    Riga, LV-1004, Latvia

  • Novartis Investigative Site

    Kaunas, LTU, LT 50161, Lithuania

  • Novartis Investigative Site

    Mexico City, D F, 06700, Mexico

  • Novartis Investigative Site

    Distrito Federal, 03310, Mexico

  • Novartis Investigative Site

    Rotterdam, South Holland, 3015 CN, Netherlands

  • Novartis Investigative Site

    Lodz, 93-338, Poland

  • Novartis Investigative Site

    Lublin, 20-093, Poland

  • Novartis Investigative Site

    Poznan, 60-355, Poland

  • Novartis Investigative Site

    Wroclaw, 54-049, Poland

  • Novartis Investigative Site

    Bucharest, 041914, Romania

  • Novartis Investigative Site

    Kazan', 420043, Russia

  • Novartis Investigative Site

    Moscow, 119602, Russia

  • Novartis Investigative Site

    Moscow, 119991, Russia

  • Novartis Investigative Site

    Novosibirsk, 630087, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197110, Russia

  • Novartis Investigative Site

    Belgrade, 11000, Serbia

  • Novartis Investigative Site

    Bratislava, 833 40, Slovakia

  • Novartis Investigative Site

    Vigo, Pontevedra, 36212, Spain

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903, Spain

  • Novartis Investigative Site

    Madrid, 28006, Spain

  • Novartis Investigative Site

    Málaga, 29010, Spain

  • Novartis Investigative Site

    Seville, 41009, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, Balcova, 35340, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    Kharkiv, 61068, Ukraine

  • Novartis Investigative Site

    West Midlands, Birmingham, B4 6NH, United Kingdom

  • Novartis Investigative Site

    Edinburgh, EH9 1LF, United Kingdom

  • Novartis Investigative Site

    London, NW1 2BU, United Kingdom

  • Novartis Investigative Site

    London, WC1N 3JH, United Kingdom

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • San Jorge Childrens Hospital

    Santurce, 00912, Puerto Rico

  • UAB Childrens Hospital Harbor Center Neurology Dept

    Birmingham, Alabama, 35294, United States

  • UCSF

    San Francisco, California, 94115, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Utah Clinical Trials Office

    Salt Lake City, Utah, 84108, United States

  • Wayne State University

    Detroit, Michigan, 48201, United States

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