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

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: placebo
    ARM 1: Kind: Experimental
    Label: placebo
    Description: Sodium chloride
  • Botulinum toxin type A Biological
    Other Names: BOTOX®
    Intervention Desc: Botulinum toxin type A
    ARM 1: Kind: Experimental
    Label: BTX-A
    Description: Botulinum toxin type A
  • GSK1358820(Botulinum toxin type A) Drug
    Other Names: OnabotulinumtoxinA; Botox
    Intervention Desc: GSK1358820 (Botulinum Toxin Type A, also known as "OnabotulinumtoxinA" or "Botox")
    ARM 1: Kind: Experimental
    Label: GSK1358820(Botulinum Toxin Type A)
    Description: GSK1358820 (Botulinum Toxin Type A, also known as "OnabotulinumtoxinA" or "Botox")

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline at week 6 for wrist flexor muscle tone as measured on the Modified Ashworth Scale (MAS) 6 weeks No
Secondary An area under curve (AUC) for the MAS wrist score change from baseline 12 weeks No
Secondary Change from baseline at every visit post-injection, except week 6, for wrist flexor muscle tone as measured on MAS 12 weeks No
Secondary Percentage on wrist treatment responder at all post-injection visits (Treatment responder definition: subjects with a decrease in wrist flexor muscle tone of at least one point on MAS score) 12 weeks No
Secondary Change from baseline for finger flexor muscle tone as measured on MAS at all post-injection visits 12 weeks No
Secondary Change from baseline for thumb flexor muscle tone as measured on MAS at all post-injection visits 12 weeks No
Secondary Disability Assessment Scale (DAS) at all post-injection visits 12 weeks No
Secondary Global Assessment Scale evaluated by physician at all post-injection visits 12 weeks No
Secondary Global Assessment Scale evaluated by care giver or subject at all post-injection visits 12 weeks No
Secondary Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score Baseline (Day 0), Week 6, and Week 12 No
Secondary Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS Baseline (Day 0) and Weeks 1, 4, 8, and 12 No
Secondary Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits Weeks 1, 4, 6, 8, and 12 No
Secondary Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 No
Secondary Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 No
Secondary Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS) Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 No
Secondary Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points Weeks 1, 4, 6, 8, and 12 No
Secondary GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points Weeks 1, 4, 6, 8, and 12 No

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