Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: BAF312 siponimod Multiple Sclerosis Relapsing remitting Multiple Sclerosis Demyelinating Autoimmune Diseases MS RRMS inflammatory disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 185
Healthy volunteers: no

Brief summary:
This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population

Detailed description:
This study was prematurely discontinued after approximately 5 years. The decision to prematurely discontinue the study was not taken due to safety-related concerns, rather due to a decision to focus the development of siponimod in MS on a different population.

Arms:
arm 1: 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase arm 2: 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase arm 3: 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase arm 4: .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase arm 5: .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase

Interventions: intervention 1: BAF312
Intervention descriptions: intervention 1: BAF312 was supplied in film-coated tablets in strengths of 5, 4 ,2, 1, .5 and .25 mg. The actual doses taken were 10, 2, 1.25, .5 and .25 mg taken orally once a day.

Protocol document: