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
Condition: Cerebrovascular Accident
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional
Phase: Phase 3

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).
    

Detailed description: 
      The primary objective of this study is to confirm the superior efficacy of a single treatment
      session with GSK1358820 (Botulinum Toxin Type A, aslo known as "OnabotulinumtoxinA" or
      "Botox") '200U or 240U (if thumb spasticity is present)' over placebo in subjects with
      post-stroke upper limb spasticity of both wrist and fingers flexors as measured on the
      Modified Ashworth Scale (MAS).

      This trial is a multicenter, double-blind, randomized, placebo-controlled, parallel group
      study comparing GSK1358820 (Botulinum Toxin Type A, also known as "OnabotulinumtoxinA" or
      "Botox") to placebo for the treatment of subjects with focal wrist, finger and in some cases,
      thumb spasticity post-stroke. Approximately 168 subjects will be enrolled. Subjects will
      receive a single treatment session with intramuscular injections of GSK1358820 (Botulinum
      Toxin Type A, also known as "OnabotulinumtoxinA" or "Botox") '200U or 240U (if thumb
      spasticity is present)' or placebo in a randomization ration of 1:1. The subjects will be
      observed until 12 weeks post injection.

      Each completed subject will attend 7 clinic visits. The maximum study duration is 13 weeks
      per subject. The study includes a 1 week pretreatment period, during which the screening
      visit (visit 1) is to take place. Only one upper limb (meeting inclusion/exclusion criteria)
      will be evaluated and treated in the study. Subjects will receive a single intramuscular
      treatment with either investigated drug or placebo at day 0 (visit 2). There will be five
      post-injection follow-up visits at weeks 1, 4, 6, 8 and 12 (visits 3 to 7). Week 6 (visit 5)
      is designated as the primary visit for determining efficacy.

      The primary endpoint is the change from baseline at week 6 for wrist flexor muscle tone as
      measured on the Modified Ashworth Scale (MAS). The secondary endpoints include The secondary
      endpoints include the area under curve (AUC) for the MAS wrist score change from baseline,
      change from baseline for wrist/finger/thumb flexor muscle tone as measured on MAS, Disability
      Assessment Scale and Global Assessment Scale. The safety measures include adverse events,
      clinical laboratory tests and pulse, blood pressure.
    

Intervention name(s): GSK1358820(Botulinum toxin type A); placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK1358820 (Botulinum Toxin Type A, also known as "OnabotulinumtoxinA" or "Botox"); placebo
Other intervention name(s): OnabotulinumtoxinA; Botox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: efficacy; Spasticity, Post-Stroke; safety; Botulinum toxin type A; placebo; spasticity