EUCTR2012-003056-36-CZActive, not recruitingPhase 1
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 - EXPAND
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 1,530
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Prior history of relapsing remitting MS
- •Secondary progressive multiple sclerosis (SPMS) defined as progressive increase of disability in at least 6 months
- •EDSS score of 3.0 to 6.5
- •No relapse or corticosteroid treatment within 3 months
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1530
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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 exclusion criteria may apply
Investigators
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