A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity

Summary

This trial is a multicenter, double-blind, randomized, placebo-controlled study to compare GSK1358820 (Botulinum Toxin Type A, also known as "OnabotulinumtoxinA" or "Botox") with placebo on the efficacy and safety of treatment in poststroke subjects with focal wrist, finger and in some cases, thumb spasticity. Approximately 168 subjects will be enrolled. Subjects will receive a single treatment session of intramuscular GSK1358820 (Botulinum Toxin Type A, also known as "OnabotulinumtoxinA" or "Botox") '200U or 240U (if thumb spasticity is present)' or placebo in a randomization ratio of 1:1. The subjects will be observed until 12 weeks post injection. Outcome measures include changes from baseline at every post injection visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global Assessment Scale. The primary efficacy endpoint is the change from baseline at week 6 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and urinanalysis).

Timeline

Start

2010-04

Primary completion

2011-06

Completion

2011-06

Outcome

Met primary endpoint

registry Placebo vs BTX 200 U; p <0.001; Exact Smirnov test NCT01153815 ↗

Drugs

Indications