A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity

Completed

Phase 3 Results

Summary of Purpose

This trial is a multicenter, open-label study to evaluate the safety and efficacy of GSK1358820 for treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb spasticity. Qualified patients who complete GSK double-blind study 112958 will be enrolled. Subjects will receive a single treatment session of intramuscular GSK1358820 "200U or 240U (if thumb spasticity is present)". The subjects...

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 15 November 2012.

1 Sep 2010 3 Sep 2010 1 Dec 2011 1 Dec 2011 1 Oct 2012 19 Jul 2012
Start Date First Received 1st Completion Completion Verification Results

Trial Basics

Interventions

Conditions

Sponsors

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Contacts