FTY720 in Primary Progressive Multiple Sclerosis Open Label Extension

• Research type

  Research Study

• Full title

  Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis

• IRAS ID

  117755

• Contact name

  Jane Watson

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-000835-18

• ISRCTN Number

  xx

• Research summary

  Multiple Sclerosis (MS) is the most common disabling disease of the Central Nervous System (brain and spinal cord) in young adults. The cause of MS is unknown. It is an auto immune disease where white blood cells (lymphocytes) start to attack the nerves and parts of the brain.Primary Progressive Multiple Sclerosis (PPMS) is characterised by a steady worsening of symptoms in the absence of relapses. The most common presentation of PPMS is problems with walking.Patients with PPMS are given treatment for their symptoms, but to date there is no proven treatment available to treat PPMS.FTY720 (the study drug is a possible new oral treatment for PPMS) acts on the white blood cells responsible for immune reactions and make the cells move away from the sites of inflammation. The white blood cells are directed to the lymph nodes and other places where they rest. The anti-inflammatory effects of FTY720 have been shown in previous studies in other forms of MS. Preclinical data suggests that the way FTY720 works may involve CNS effects and this may be of benefit to patients with PPMS.The main purpose of this extension study is to measure how safe and well tolerated FTY720 is in the long term. All patients will have completed the CFTY720D2306 study on treatment. 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 every three months (minimum) for the first two years of the study, and every six months thereafter.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/1889

• Date of REC Opinion

  18 Mar 2013

• REC opinion

  Further Information Favourable Opinion