At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,651 enrolled
Drug / intervention
BAF312 +1 moredrug
Likely dose
BAF312 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.
In Brief
A Phase 3 clinical trial evaluating BAF312 and Placebo for Secondary Progressive Multiple Sclerosis. Completed, enrolled 1,651 participants across 290 sites in 31 countries.
Detailed Summary
Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Progressive Multiple Sclerosis
CountriesArgentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czechia, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartDec 2012
Primary CompletionApr 2016
Study CompletionMar 2023
TodayJul 2026
First PostedAug 15, 2012
Enrollment StartDec 20, 2012
Primary CompletionApr 29, 2016
Study CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.9 years ago
Interventions
BAF312drug
0.25, 0.5, 1, and 2 mg film-coated tablets
Placebodrug
Film-coated tablets