Spots Global Cancer Trial Database for Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis

Official Title: A Phase 2B Randomised, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of MIS416 in the Treatment of Subjects With Secondary Progressive Multiple Sclerosis

Study ID: NCT02228213

Conditions

Secondary Progressive Multiple Sclerosis

Interventions

MIS416

Saline

Study Description

Brief Summary: The purpose of this study is to determine whether MIS416 administered once weekly over 12 months is safe, tolerable, and improves a range of signs and symptoms associated with secondary progressive multiple sclerosis.

Detailed Description: The primary objectives of the study are to: 1. Determine the efficacy of MIS416, relative to placebo, when administered repeatedly via weekly intravenous (IV) administration to subjects with Secondary Progressive Multiple Sclerosis, as assessed by its effect on measures of neuromuscular function. 2. Determine the safety and tolerability of a weekly regimen of MIS416. The secondary objectives of the study are to: 1. Determine the effect of MIS416 on disease activity and neurodegeneration by assessing changes in Magnetic Resonance Imaging (MRI) markers including lesions, whole brain atrophy (WBA) and Magnetization Transfer Ratio (MTR). 2. Determine the effect of MIS416 on Patient Reported Outcomes (PRO) related to disability and health status. 3. Assess, in a subset of subjects, the pharmacodynamic (PD) effects of MIS416, including effects on serum, Peripheral Blood Mononuclear Cell (PBMC), and Cerebral Spinal Fluid (CSF) cytokine/chemokine levels and expression patterns.