NOGO-A in Multiple Sclerosis FTIH
The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth.
The trial is expected to involve approximately 36 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses in patients with Multiple Sclerosis (MS).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Patients With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying Therapy.|
- The preliminary safety and tolerability of single doses of GSK1223249 [ Time Frame: screening, baseline (pre-dose) and up to 84 days post dose ] [ Designated as safety issue: Yes ]changes in Vital signs, Electocardiogram, safety laboratory samples, adverse event (AE), neurological examination and MS relapses
- Single dose pharmacokinetics. [ Time Frame: screening, baseline (pre-dose) and up to 84 days post dose ] [ Designated as safety issue: No ](AUC(0-∞)
|Study Start Date:||February 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Other Name: Placebo
This is a phase I study of GSK1223249. The study design is randomized, placebo-controlled, double-blind, sequential dose escalation, single dose administration. Approximately 36 patients with relapsing forms of Multiple Sclerosis (having had at least two relapses over the previous 24 months, OR at least one relapse within the last 12 months, OR having had at least one documented gadolinium-enhancing lesion on brain magnetic resonance imaging (MRI) within 12 months prior to Screening) will be enrolled.