Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
Description
Detailed 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.
Phase
N/AInclusion and Exclusion 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.
- Subjects with severe bleeding disorders, platelet count less than (<)50,000/microliters (
Sites
Please contact Fatima (Pat) Gutierrez to learn more about where you can participate in this trial. Please use the contact form on the right side.
Presentado por
SC CTSI