Project

Selective S1P1 receptor agonist in Patients with Relapsing-Remitting Multiple Sclerosis

Completed · 2009 until 2010

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2009
End Date
2010
Financing
Industry
Study Design
Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding phase IIb study
Keywords
MS, S1P1 receptor agonist, phase II
Homepage
Brief description/objective

Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding phase IIb study to evaluate the efficacy, safety, and tolerability of three doses of an oral S1P1 receptor agonist, administered for twenty-four weks in patients with relapsing-remitting multiple sclerosis

Primary Outcome meassures:
culmulative number of new gadolinium lesions T1-weighted MRI at weeks 12/16/20/24

Secondary objectives:
- annualized confirmed relapse rate
- time to first confirmed relapse
- safety and tolarability