An extension study in patients with Relapsing-Remitting MS

• Research type

  Research Study

• Full title

  An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis (RRMS).

• Contact name

  Basil Sharrack

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2007-004122-24

• ISRCTN Number

  n/a

• Research summary

  This study is an extension study of the 24-month, double-blind, randomised, multicenter, placebo-controlled, parallel-group study comparing the effectiveness and safety of the study drug FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis (RRMS).Multiple Sclerosis (MS) is a disease of the nervous system which affects nerve function, resulting in patient disability. There are no oral therapies available on the market for the chronic treatment of MS. FTY720 has not been approved yet for the treatment of patients with multiple sclerosis. It acts on the immune system with a mechanism of action that offers a new approach to the treatment of MS. The main purpose of this study is to see how safe and well tolerated FTY720 is when used for a longer time. It will also continue to evaluate how effective FTY720 is in reducing the number of relapses and in delaying disability progression in patients with relapsing-remitting MS. About 1000 patients with relapsing MS will join in this extension study at about 130 hospitals/clinics worldwide. Participants will be asked to come to the study site at least 6 times in the first year and at least 4 times for each year thereafter. The extension study is expected to continue until the drug is commercially available or until the development of the drug is stopped. The treatments for the extension study are as follows: ?½ FTY720 1.25 mg (1 capsule a day) for 24 months or FTY720 0.5 mg (1 capsule a day) for 24 months If the participant received placebo in the core study they will be randomly assigned (like flipping a coin) to either 0.5 mg FTY720 or 1.25 mg FTY720 in the extension study.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  08/H0605/118

• Date of REC Opinion

  14 Oct 2008

• REC opinion

  Further Information Favourable Opinion