Spots Global Cancer Trial Database for Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
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Trial Identification
Brief Title: Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
Official Title: Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
Study ID: NCT02330965
Conditions
Study Description
Brief 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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Jordan Research & Education Institute: Sutter Alta Bates Summit, Berkeley, California, United States
University of Southern California, Los Angeles, California, United States
University of California, Davis, Sacramento, California, United States
University of Colorado, Aurora, Colorado, United States
University of Michigan Health System -Multiple Sclerosis Center, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Minneapolis Clinic of Neurology, Golden Valley, Minnesota, United States
University of New Mexico: Health Sciences Center, Albuquerque, New Mexico, United States
South Shore Neurologic Associates - Multiple Sclerosis Care Center, Patchogue, New York, United States
Carolinas Medical Center (CMC), Charlotte, North Carolina, United States
Cleveland Clinic: Mellen Center for Multiple Sclerosis, Cleveland, Ohio, United States
Providence Multiple Sclerosis Center, Portland, Oregon, United States
Swedish Neuroscience Institute, Seattle, Washington, United States
Contact Details
Name: Yang Mao-Draayer, MD, PhD
Affiliation: Multiple Sclerosis Center - University of Michigan Health System
Role: STUDY_CHAIR
Name: David Fox, MD
Affiliation: Division of Rheumatology - University of Michigan Health System
Role: STUDY_CHAIR
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