NCT02330965

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Secondary Progressive Multiple Sclerosis

Interventions

Type	Name	Description
PROCEDURE	Blood Draw	Blood draws (65 mLs \[\~4 tablespoons\] per blood draw) at 4 time points: Prior to study medication initiation, and at +6, +12 and+24 months post treatment initiation.
PROCEDURE	CSF collection by lumbar puncture (Optional)	For participants who volunteer to donate CSF samples: up to 25 mLs (\<2 tablespoons): prior to study medication initiation, and at month 24 post treatment initiation.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-07-12
• Completion: 2017-07-12
• First posted: 2015-01-05
• Last updated: 2020-11-09

Locations

13 sites across 1 country: United States