Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis. Relapse-remitting Fingolimod
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 920
Healthy volunteers: no

Brief summary:
This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).

Detailed description:

Arms:
arm 1: Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study. arm 2: Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study. arm 3: Patients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study. arm 4: Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study. arm 5: Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study.

Interventions: intervention 1: Fingolimod 0.5 mg intervention 2: Fingolimod 1.25 mg
Intervention descriptions: intervention 1: Patients self-administered fingolimod 0.5 mg capsules orally once daily. intervention 2: Patients self-administered fingolimod 1.25 mg capsules orally once daily.

Protocol document: