Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
Secondary Progressive Multiple Sclerosis
About this trial
This is an interventional treatment trial for Secondary Progressive Multiple Sclerosis focused on measuring Secondary Progressive Multiple Sclerosis
Eligibility Criteria
Inclusion 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
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 inclusion/exclusion may apply.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Siponimod (BAF312)
Placebo
Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on the treatment epoch for 3 months. During the Core Part of the study, participants participated in a maximum of 3 epochs. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312.
Matching placebo to BAF312 was administered orally during the Core Part of the trial. Following the Core Part, eligible participants enter the Extension Part during which all receive open-label BAF312.