Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Core Study

Inclusion Criteria:

• Diagnosis of relapsing multiple Sclerosis (MS)
• Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
• Patients with an Expanded Disability Status Scale (EDSS) score of 0-6

Extension Study

• A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)
• Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods.
• Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.

Exclusion Criteria:

Core Study

• Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
• Pregnant or nursing women

Extension Study

• Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study
• Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)

Other protocol-defined inclusion/exclusion criteria may apply