Loading clinical trials...
Loading clinical trials...
Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis
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.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
GSK Investigational Site
Sofia, Bulgaria
GSK Investigational Site
Sofia, Bulgaria
GSK Investigational Site
Sofia, Bulgaria
GSK Investigational Site
Calgary, Alberta, Canada
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Gatineau, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Jihlava, Czechia
GSK Investigational Site
Olomouc, Czechia
Start Date
February 1, 2013
Primary Completion Date
September 1, 2014
Completion Date
September 1, 2014
Last Updated
August 16, 2016
131
ACTUAL participants
GSK239512
DRUG
Placebo
DRUG
Lead Sponsor
GlaxoSmithKline
NCT05359653
NCT06390930
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions