Conditions: Primary Progressive Multiple Sclerosis
Keywords: FTY720, primary progressive multiple sclerosis,PPMS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 970
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population

Detailed description:

Arms:
arm 1: Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment arm 2: Cohort 1 and 2: Patients randomized to placebo continued on placebo after re-randomization arm 3: Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment on Nov 2009

Interventions: intervention 1: FTY720 intervention 2: Placebo
Intervention descriptions: intervention 1: Fingolimod capsules at doses of 1.25 mg (prior to implementation of Amendment 5) and 0.5 mg (after Amendment 5) were administered orally once daily intervention 2: Matching placebo capsules were administered orally once daily

Protocol document: