Conditions: Multiple Sclerosis
Keywords: FTY720 multiple sclerosis MS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief summary:
This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.

Detailed description:
A decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day in an amendment to the study protocol. The study became open-label with all patients receiving fingolimod 0.5 mg/day on 22 Feb 2010.

The efficacy data for Months 0-6 in this study report is from the core study NCT00537082.

Arms:
arm 1: Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study. arm 2: Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study. arm 3: Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.

Interventions: intervention 1: Fingolimod
Intervention descriptions: intervention 1: Fingolimod was supplied in capsules.

Protocol document: