Paediatric MS patients - Fingolomid versus interferon
Research type
Research Study
Full title
A two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis
IRAS ID
148157
Contact name
Cheryl Hemingway
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2011-005677-23
Research summary
Multiple Sclerosis (MS) is the most common disabling disease of the Central Nervous System (brain and nerves of the spinal cord) in young adults.
The cause of MS is unknown. It is an autoimmune disease, where the white blood cells (lymphocytes) start to attack the nerves and parts of the brain. There are several types of MS the most common type is known as relapsing remitting MS (RRMS). Patients with RRMS have repeated acute episodes of neurological symptoms(relapses), which are followed by a complete or partial recovery (remission).
Fingolimod (FTY720 the study drug) is a possible new treatment for MS. It is taken once daily as a tablet. Fingolimod acts on the white bloods cells responsible for immune reactions and make cells move away from the sites of inflammation. The white blood cells are redirected to the lymph nodes and other places where they normally rest.
Previous studies with fingolimod showed a significant decrease in the number of relapses per patient. This study is a 2 year study to look at the efficacy and safety of fingolimod compared to IFN ß1a (Interferon Beta) in children/adolescent patients aged 10-17years. If suitable for the study eligible patients will be randomised to one of the two treatment arms(fingolimod or Interferon Beta).
REC name
London - Bloomsbury Research Ethics Committee
REC reference
14/LO/0378
Date of REC Opinion
15 Jul 2014
REC opinion
Further Information Favourable Opinion