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

Completed · Has a placebo group

Conditions studied: Secondary Progressive Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02330965

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Starts

2014-12-01

Expected to finish

2017-07-12

Last updated by the study team

2020-11-09

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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