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Study on the Safety and Effectiveness of Fingolimod and Interferon Beta-1a in Children with Multiple Sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Multiple Sclerosis, a disease that affects the brain and spinal cord, leading to a range of symptoms such as fatigue, difficulty walking, and vision problems. The study is evaluating the safety and effectiveness of a medication called fingolimod, which is taken as a capsule by mouth. Fingolimod is being compared to another treatment called interferon β-1a, which is given as an injection once a week. The purpose of the study is to understand how well fingolimod works and how safe it is for children with multiple sclerosis.

The study is designed to last for two years, during which participants will receive either fingolimod or interferon β-1a. After this period, there is an additional five-year phase where participants may continue to receive fingolimod. Throughout the study, researchers will monitor the participants' health and any changes in their symptoms. This will help determine the long-term effects of fingolimod on aspects such as cognitive function, which involves thinking and memory, and physical and sexual development.

Participants will be randomly assigned to receive either fingolimod or interferon β-1a, and neither the participants nor the researchers will know which treatment each participant is receiving. This is known as a "double-blind" study. The study aims to provide valuable information on the potential benefits and risks of using fingolimod in young patients with multiple sclerosis, contributing to better treatment options in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation begins in the Core Phase, which lasts for two years. This phase is designed to evaluate the safety and effectiveness of the medication fingolimod in children with multiple sclerosis.

  2. Step 2

    Medication administration

    During the Core Phase, fingolimod is taken orally once a day. The medication is available in two dosages: 0.5 mg and 0.25 mg hard capsules. The appropriate dosage is determined based on specific criteria, including age, weight, and developmental stage.

  3. Step 3

    Comparison treatment

    The study involves a comparison between fingolimod and another treatment, interferon β-1a, which is administered once a week through an injection into the muscle. This comparison helps to assess the relative safety and effectiveness of fingolimod.

  4. Step 4

    Extension phase

    After completing the Core Phase, participants may enter a five-year Extension Phase. This phase continues to monitor the long-term effects of fingolimod on safety, cognitive function, and physical development.

  5. Step 5

    Monitoring and assessments

    Throughout the study, regular assessments are conducted to monitor the annualized relapse rate, the presence of new or enlarged brain lesions, and changes in brain volume. These assessments help to evaluate the ongoing impact of the treatment.

Who can join the trial?

4 criteria

  • Patients must have completed the initial part of the study, called the Core Phase, whether they were taking the study drug or not.
  • New patients joining the study must meet the health guidelines approved in their country for children. This includes being 12 years old or younger, weighing 40 kg or less, or being in an early stage of puberty (known as Tanner stage less than 2).
  • In countries where a lower dose of the study drug is not approved, new patients must weigh more than 40 kg and take a higher dose as per local guidelines.
  • All new patients must have their diagnosis of pediatric **Multiple Sclerosis** confirmed through a central review, which includes an initial **MRI** report. An **MRI** is a type of scan that helps doctors see inside the body.

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to the study medication.
  • Patients with certain heart conditions that could be worsened by the study medication.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of cancer, except for certain types of skin cancer.
  • Patients with liver disease that is not well managed.
  • Patients who have an active infection that requires treatment.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who are unable to follow the study procedures or attend study visits.
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Investigated drugs

  • Fingolimod

    is a medication taken by mouth once a day. It is used in this trial to treat pediatric patients with multiple sclerosis. The study aims to evaluate how safe and effective fingolimod is over a long period. It also looks at how fingolimod affects cognitive function and physical and sexual development in children.

  • Interferon β-1a

    is another medication used in this trial. It is given as an injection once a week. The trial compares the safety and effectiveness of interferon β-1a with fingolimod in treating pediatric patients with multiple sclerosis. The study also examines how patients who initially received interferon β-1a respond to fingolimod in the long term.

What is already known about the treatment

  • Fingolimod

    Fingolimod is administered orally in the form of a capsule taken once daily. It is currently approved for use in treating multiple sclerosis and is well-documented in medical literature for its effectiveness in managing this condition. The main therapeutic indication for fingolimod is to reduce the frequency of relapses and delay the progression of physical disability in patients with multiple sclerosis. At the molecular level, fingolimod works by modulating the sphingosine 1-phosphate receptor, which helps to retain certain white blood cells in the lymph nodes, preventing them from reaching the central nervous system and causing damage. It is classified as a sphingosine 1-phosphate receptor modulator.

  • Interferon beta-1a

    Interferon beta-1a is administered through an intramuscular injection once weekly. It is a well-established treatment for multiple sclerosis, with extensive documentation in medical literature supporting its use. The primary therapeutic indication is to reduce the frequency of relapses and slow the progression of disability in patients with multiple sclerosis. Its mechanism of action involves modulating the immune system to reduce inflammation and prevent immune cells from attacking the nervous system. Interferon beta-1a is classified as an immunomodulator.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. Symptoms can vary widely, including fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of the disease can be unpredictable, with periods of remission and relapses. The severity and specific symptoms can differ greatly from person to person.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-507556-68-00Protocol codeCFTY720D2311Estimated enrolment41 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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