Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
Trial ID or NCT#
Status
Purpose
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).
Official Title
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.
Eligibility Criteria
- - Prior history of relapsing remitting MS - SPMS defined as progressive increase of disability over at least 6 months - EDSS score of 3.0 to 6.5 - No relapse of corticosteroid treatment within 3 months
- - Women of child bearing potential must use reliable forms of contraception. - Diagnosis of Macular edema during screening period - Any medically unstable condition determined by investigator. - Unable to undergo MRI scans - Hypersensitivity to any study drugs or drugs of similar class Other protocol defined inclusion/exclusion may apply.
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Contact
Angela Campbell
650-721-6188
View on ClinicalTrials.gov