Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment

Allergan62 enrolled

Overview

This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A treatment in poststroke patients with spasticity of the upper-limb flexors

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke Muscle Spasticity

Interventions

Botulinum Toxin Type ABIOLOGICAL

200 U to 360 U of botulinum toxin Type A on Day 0. Patients who met retreatment criteria received a second treatment (open-label) at Week 12 or Week 18

PlaceboBIOLOGICAL

Saline injection on Day 0

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Medically stable poststroke with focal unilateral upper-limb spasticity Exclusion Criteria: * Stroke within 6 months of the study enrollment visit * Previous or current botulinum toxin therapy of any type in the study limb

Locations (1)

Unnamed facility

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Seven functional tasks (nail filing, hand cleaning, holding a water bottle, brushing teeth, holding a small fruit, holding a medium fruit, and holding a large fruit)

Time frame: Week 6

Secondary Outcomes

Spasticity of the upper-limb flexors as measured by the Ashworth Scale

Time frame: Week 6

Data from ClinicalTrials.gov

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