Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod
 compared to placebo on efficacy parameters in patients with relapsing-remitting multiple
 sclerosis (RRMS).
This randomized, multicenter, parallel-group study consisted of 2 phases: a 24-month
 double-blind, randomized, multicenter, placebo-controlled, parallel-group study and an
 Extension phase which consisted of a dose-blinded period and an open-label period.

 In the Core phase, patients were randomized to receive a fixed dose of fingolimod (0.5
 mg/day), fingolimod (1.25 mg/day) or placebo for up to 24 months.

 For the Extension phase, patients who were treated with fingolimod during the Core phase
 continued treatment at the assigned dose level, while those previously treated with placebo
 during the Core phase were re-randomized in a 1:1 ratio to receive one of the two doses of
 fingolimod (1.25 mg or 0.5 mg). All patients in the extension received blinded
 investigational drug: fingolimod 1.25 mg and 0.5 mg in capsules for oral administration once
 daily until the decision to discontinue the fingolimod 1.25 mg dose became effective and
 subsequently all patients were switched to open-label fingolimod 0.5 mg.

 With the implementation of Amendment 11, the 1.25 mg dose was discontinued and all patients
 were switched to fingolimod 0.5 mg dose. With the implementation of Amendment 12, all
 patients treated with Placebo in the fingolimod Core phase were switched to treatment with
 0.5 mg fingolimod per day. The Extension phase continued until all patients either
 discontinued or transferred to Study CFTY720D2399 (NCT01201356; initiated in September 2010).
Inclusion Criteria:

 -  Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis

 -  Patients with a relapsing-remitting disease course

 -  Patients with expanded disability status scale (EDSS) score of 0-5.5

 Exclusion Criteria:

 -  Patients with other chronic disease of the immune system, malignancies, acute
 pulmonary disease, cardiac failure, etc.

 -  Pregnant or nursing women

 For inclusion in the extension phase patients should complete the 24 month core study with
 or without 24 months on study drug. If a patient discontinued study drug during the core
 study due to an adverse event, serious adverse event, laboratory abnormality etc. they
 would be excluded from the Extension Phase.

 Other protocol-defined inclusion/exclusion criteria may apply.