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

Allergan

Status and phase: Completed; Phase 2

Conditions: Stroke; Muscle Spasticity

Treatments: Biological: Placebo; Biological: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651690

191622-065

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Botulinum Toxin Type A

Treatment:

Biological: Botulinum Toxin Type A

2

Placebo Comparator group

Description:

Saline

Treatment:

Biological: Placebo