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

Allergan

Status and phase: Completed; Phase 2

Conditions: Stroke; Muscle Spasticity

Treatments: Biological: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651729

191622-056

Details and patient eligibility

About

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

Enrollment: 279 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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279 participants in 1 patient group

1

Experimental group

Description:

Botulinum Toxin Type A

Treatment:

Biological: Botulinum Toxin Type A