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Clinical Trials/NCT00651729
NCT00651729
Completed
Phase 2

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

Allergan0 sites279 target enrollmentApril 2003

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stroke
Sponsor
Allergan
Enrollment
279
Primary Endpoint
Adverse events
Status
Completed
Last Updated
17 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2003
End Date
December 2004
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Allergan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Adverse events

Time Frame: Week 54

Secondary Outcomes

  • Spasticity as measured by the Ashworth scale(Week 54)

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