Clinical trial NCT01153815
Conditions: Cerebrovascular Accident
Keywords: efficacy Spasticity, Post-Stroke safety Botulinum toxin type A placebo spasticity
Sponsor: GlaxoSmithKline
Start date: 2010-04-01; Completion date: 2011-06-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Sodium chloride arm 2: GSK1358820 (Botulinum Toxin Type A, also known as "OnabotulinumtoxinA" or "Botox")
Interventions: intervention 1: GSK1358820(Botulinum toxin type A) intervention 2: placebo
Intervention descriptions: intervention 1: GSK1358820 (Botulinum Toxin Type A, also known as "OnabotulinumtoxinA" or "Botox") intervention 2: placebo

Protocol documents: