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

Phase 2

Completed

• Conditions: Stroke; Muscle Spasticity
• Interventions: Biological: Botulinum Toxin Type A

• Registration Number: NCT00651729
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-03
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-23
• Last Update Posted: 2008-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Botulinum Toxin Type A	Botulinum Toxin Type A

Primary Outcome Measures

Name	Time	Method
Adverse events	Week 54

Secondary Outcome Measures

Name	Time	Method
Spasticity as measured by the Ashworth scale	Week 54