New phase II study

[dignan]

Here's one that got caught up in the tysabri storm and is now ready to restart the trial process after being asked to halt by the FDA in 2005. On the bright side, it's a pill.



Study of SB-683699 Compared to Placebo in Subjects With Relapsing-Remitting Multiple Sclerosis (MS)

This study is not yet open for patient recruitment.

Verified by GlaxoSmithKline November 2006

Purpose
SB-683699 is an oral medication that is thought to reduce the number of active white blood cells entering the brain; these white blood cells are part of the disease process for MS. This study will look at whether different doses of SB-683699 are effective and safe in patients with relapsing remitting MS.

Phase II
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of SB-683699 in Subjects With Relapsing-Remitting Multiple Sclerosis

Further study details as provided by GlaxoSmithKline:
Primary Outcomes: MRI lesions at 6 months

Secondary Outcomes: Number of relapses at 6 months; Expanded Disability Status Scale at 6 months; Multiple Sclerosis Functional Composite at 6 months; Safety and tolerability of SB-683699 e.g. vital signs, laboratory parameters, adverse Events over 6 months

Expected Total Enrollment: 350

Study start: January 2007

http://www.clinicaltrials.gov/ct/show/N ... 7?order=34