Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis
Status:
Completed
Trial end date:
2015-01-22
Target enrollment:
Participant gender:
Summary
This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel group
investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249) compared
to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a screening period
of up to four weeks, eligible subjects will be randomised (1:1) to receive IV placebo or 15
milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of 48 weeks with a
follow-up visit around 14 weeks after the last infusion. A total of approximately 294
eligible subjects will be randomised from approximately 37 centers worldwide. The primary
objective is to assess the effect of ozanezumab on the physical function and survival of ALS
subjects over a treatment period of 48 weeks. Function will be measured using the ALS
Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives include the evaluation of
other clinical outcomes associated with ALS (respiratory function, muscle strength,
progression free survival and overall survival) in support of the primary objective. Quality
of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole)
will also be assessed.