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

Allergan279 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

279

Conditions

Stroke Muscle Spasticity

Interventions

Botulinum Toxin Type ABIOLOGICAL

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Medically stable poststroke patients with spastic muscles in the upper limb Exclusion Criteria: * Stroke within 6 months of study enrollment * Previous therapy with Botulinum Toxin Type A for treatment of any condition prior to 4 months of enrollment, for treatment of any condition prior to 01 January 1998

Locations (2)

Unnamed facility

Indianapolis, Indiana, United States

Unnamed facility

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Adverse events

Time frame: Week 54

Secondary Outcomes

Spasticity as measured by the Ashworth scale

Time frame: Week 54

Data from ClinicalTrials.gov

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