Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 60
Updated:11/9/2017
Start Date:December 2014
End Date:July 12, 2017

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Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)

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.

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.

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.
We found this trial at
13
sites
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Albuquerque, New Mexico 87131
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Aurora, Colorado 80045
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Berkeley, CA
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Charlotte, North Carolina 28207
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Cleveland, OH
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Detroit, Michigan 48202
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Golden Valley, Minnesota 55422
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Patchogue, NY
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Portland, Oregon 97225
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
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Seattle, Washington 98122
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