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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia Bucharest Romania
Universitaetsmedizin Goettingen Goettingen Germany
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Pellegrin Hospital Bordeaux France
Katholisches Klinikum Bochum gGmbH Bochum Germany
Narodny Ustav Detskych Chorob Bratislava Slovakia
Institut Des Neurosciences De La Timone Marseille France
Universitaetsklinikum Erlangen AöR Erlangen Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Hospital Alvaro Cunqueiro Vigo Spain
Hsgcidwk Umwzqordexcep Dz Lh Pwfagsyw Madrid Spain
Cvl Kjfgeen Bwihdil Le Kremlin-Bicetre France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
26.07.2013
Germany Germany
Not recruiting
26.07.2013
Romania Romania
Not recruiting
26.07.2013
Slovakia Slovakia
Not recruiting
26.07.2013
Spain Spain
Not recruiting
26.07.2013

Trial locations

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.

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 ID:
2023-507556-68-00
Protocol code:
CFTY720D2311
Trial Phase:
Therapeutic confirmatory (Phase III)

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