Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
This is a randomized, parallel group, placebo-controlled study designed to assess whether
GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple
Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex
(Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects
will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be
managed with their current standard of care therapy (Copaxone or Avonex). The total treatment
period is 48 weeks, including a standard 4 week titration period and 44 week maintenance
treatment period (which could be adapted to a 5-week titration and 43 week maintenance
period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg
(10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will
be titrated to the maximum tolerated dose with the objective of titrating to the highest dose
(80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The
post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of
treatment at Week 48 or early withdrawal, as appropriate.