CFTY720D2316 FTY720 safety and health outcomes in relapsing MS v1
Research type
Research Study
Full title
A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.
IRAS ID
47469
Contact name
Richard Leaback
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2010-019029-32
ISRCTN Number
n/a
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 auto-immune 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. The main purpose of this study is to measure how safe and well tolerated fingolimod is in a broader population than previously studied. Each patient who signs consent and meets inclusion criteria, will undergo examinations to determine that they are eligible to join the study. All patients who enter the study will receive active study medication. Each patient will visit the clinic 6 times over a period of 28 weeks.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
10/H0904/20
Date of REC Opinion
7 May 2010
REC opinion
Favourable Opinion