Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial.

ABSTRACT:

Objective

This double-blind, placebo-controlled, dose-finding phase IIb study evaluated the efficacy and safety of ponesimod, an oral selective S1P1 receptor modulator, for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).

Methods

464 patients were randomised to receive once-daily oral ponesimod 10, 20 or 40 mg, or placebo for 24 weeks. The primary endpoint was the cumulative number of new T1 gadolinium-enhanced (T1 Gd+) lesions per patient recorded every 4 weeks from weeks 12 to 24 after study drug initiation. Secondary endpoints were the annualised confirmed relapse rate (ARR) and time to first confirmed relapse. Safety and tolerability were also evaluated.

Results

The mean cumulative number of new T1 Gd+ lesions at weeks 12-24 was signif

SUBMITTER: Olsson T 

PROVIDER: S-EPMC4215282 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature