Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis efficacy ozanezumab safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 304
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Administered by IV route. Treatment period - 48 Weeks arm 2: Normal saline by IV route. Treatment period - 48 weeks

Interventions: intervention 1: Ozanezumab intervention 2: Placebo
Intervention descriptions: intervention 1: Ozanezumab injection solution intervention 2: Normal saline (0.9% sodium chloride) infusion

Protocol document: