Safety Study of Botulinum Toxin Type A for the Treatment of Focal Upper Limb Poststroke Spasticity

Completed

Phase 2 Results N/A

Trial Description

The purpose of this study is to evaluate the safety of repeated doses of Botulinum Toxin Type A for the treatment of focal upper limb poststroke spasticity

Conditions

Interventions

  • Botulinum toxin type A Biological
    Other Names: BOTOX®
    Intervention Desc: Each patient received from 1 to 5 treatments, with a minimum of 12 weeks between treatments. For each treatment, a total dose of 200 U to 400 U botulinum toxin Type A was injected into the wrist and finger flexor muscles of the affected upper limb, not to exceed 6 U/kg
    ARM 1: Kind: Experimental
    Label: 1
    Description: Botulinum Toxin Type A

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Adverse events Week 54 Yes
Secondary Spasticity as measured by the Ashworth scale Week 54 No

Sponsors