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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651690

Enrollment

Registered

2008-04-03

Start date

2004-03-31

Completion date

2005-05-31

Last updated

2008-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Spasticity, Stroke

Brief summary

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

Interventions

BIOLOGICALBotulinum Toxin Type A

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

BIOLOGICALPlacebo

Saline injection on Day 0

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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)	Week 6

Secondary

Measure	Time frame
Spasticity of the upper-limb flexors as measured by the Ashworth Scale	Week 6

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026