Multiple Sclerosis Clinical Trial
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
Summary
The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.
Full Description
This study is complementary to a multi-center, randomized, double-blind,parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of BAF312 to placebo in patients with SPMS (NCT01665144). Investigators will explore both immunological and neuroprotective mechanisms of BAF312 (siponimod), a novel agent in the setting of a SPMS clinical trial.
This study is part of a multi-center study, with the University of Michigan serving as the central site.
Eligibility Criteria
Inclusion Criteria:
Participants enrolled in the multicenter, randomized, double-blind, parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of BAF312 to placebo in patients with Secondary Progressive Multiple Sclerosis (SPMS) Protocol No. CBAF312A2304 (sponsored by Novartis). Refer to ClinicalTrials.gov record NCT01665144.
Subjects enrolled at one of the participating AMS04 study sites located in the United States.
Subject must be able to provide written informed consent.
Exclusion Criteria:
Subjects with severe bleeding disorders, platelet count less than (<)50,000/microliters (μL), and/or who are currently on full anticoagulant therapy will be excluded from the optional CSF collections.
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There are 13 Locations for this study
Berkeley California, 94705, United States
Los Angeles California, 90033, United States
Sacramento California, 95817, United States
Aurora Colorado, 80045, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Golden Valley Minnesota, 55422, United States
Albuquerque New Mexico, 87131, United States
Patchogue New York, 11772, United States
Charlotte North Carolina, 28207, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97225, United States
Seattle Washington, 98122, United States
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