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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Muscle Spasticity
• Intervention / Treatment: Biological: Botulinum Toxin Type A

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
• United States
  • Indiana
    • Indianapolis, Indiana, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Botulinum Toxin Type A	Biological: Botulinum Toxin Type A; Each patient received from 1 to 5 treatments, with a minimum of 12 weeks between treatments. For each treatment, a total dose of 200 U to 400 U botulinum toxin Type A was injected into the wrist and finger flexor muscles of the affected upper limb, not to exceed 6 U/kg; Other Names: BOTOX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events	Week 54

Secondary Outcome Measures

Outcome Measure	Time Frame
Spasticity as measured by the Ashworth scale	Week 54

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Elovic EP, Barron RL, Liu J, Turkel CC. Resource utilization, productivity, and caregiver burden impact in a trial of repeated doses of botulinum toxin type A for the treatment of focal upper-limb poststroke spasticity: A multicenter open-label study. Arch Phys Med Rehabil 2005;86(9):E46 ABS-Poster 239
• Elovic EP, Brashear A, Kaelin D, McIntosh R, Liu J, Turkel CC. Safety and efficacy of repeated botulinum toxin type A treatments for focal upper-limb poststroke spasticity: Results of a 12-month multicenter, open-label trial. Arch Phys Med Rehabil 2005,86(9):E46-7 ABS-Poster 242.
• Mayer N, Barron RL, Liu J, Turkel CC. The burden of illness associated with loss of function after stroke in patients with arm spasticity enrolled in a multicenter open-label study. Arch Phys Med Rehabil 2005;86(9):E47 ABS-Poster 243
• Childers MK, Barron RL, Patel RK, Turkel CC. Health utility and quality of life following botulinum toxin type A in repeated doses for the treatment of focal upper-limb spasticity in stroke patients: A multicenter open-label study. Arch Phys Med Rehabil 2005;86(9):E48 ABS-Poster 249
• Mayer N, Barron R, Liu J, Turkel C. The burden of illness associated with loss of function after stroke in patients with arm spasticity enrolled in a multicenter open-label study. Arch Phys Med Rehabil 2006 Oct;87(10):E46-7 POS-Poster 54.
• Elovic E, Kaelin D, Brashear A, McIntosh R, Liu J, Barron R. Safety and efficacy of repeated botulinum toxin type A for focal upper-limb poststroke spasticity in patients aged 65 and older in a 12-month multicenter open-label trial. Arch Phys Med Rehabil 2006 Oct;87(11):E50 ABS-PR_272
• Elovic E, rashear A, Kaelin D, Abu-shakra S, VanDenburgh A, Turkel CC, Beddingfield III F. The effect of repeated treatment of botulinum toxin type A on poststroke, spasticity-related pain: A subgroup analysis of patients in a 12-month trial. Arch Phys Med Rehabil 2007 Sep;88(10):E4 ABS-Article 13.
• Elovic E, Brashear A, Kaelin D, Liu J, VanDenburgh AM, Beddingfield III F. The effect of repeated treatment of botulinum toxin type A on poststroke, spasticity-related pain: A subgroup analysis of patients in a 12-month trial. Arch Phys Med Rehabil 2007 Sep;88(9):E65 ABS-Poster 195
• Childers MK, Barron RL, Patel RK, Turkel CC. A multi-center open label study of botulinum toxin type A (BoNT/A) treatment of focal upper limb post-stroke spasticity: Health utility and quality of life assessment. Can Assoc Phys Med & Rehabil Annual Meeting 2006;(Online):ABS-CL-47
• Elovic E, Barron RL, Lui J, Turkel CC. Repeated doses of botulinum toxin type A (BoNT/A) for the treatment of post-stroke focal upper limb spasticity: Assessments of resource utilization, caregiver burden, and productivity. Can Assoc Phys Med & Rehabil Annual Meeting 2006;(Online):ABS-CL-49
• Elovic E, Brashear A, Kaelin D, McIntosh R, Lui J, Turkel C. Assessment of safety and efficacy of multiple botulinum toxin type A (BoTN/A) injections for post-stroke focal upper limb spasticity: A one year-long multicenter, open-label trial. Can Assoc Phys Med & Rehabil Annual Meeting 2006;(Online):ABS-CL-51
• Elovic E, Brashear A, Kaelin D, McIntosh R, Liu J, Turkel CC. Safety and efficacy of repeated botulinum toxin type A (BoNTA) in the treatment of poststroke, upper limb spasticity: A 12-month trial. Mov Disord 2006;21(Suppl 15):S423 ABS-P347
• Elovic E, Brashear A, Kaelin D, McIntosh R, Liu JY, Barron R, Turkel C. Safety and efficacy of repeated botulinum toxin type A for focal upper limb poststroke spasticity in patients aged 65 years and older in a 12-month multicenter open-label trial. Neurology 2006 14 Mar;66(5 Suppl 2):A297-8 ABS-P05.156
• Slavic E, Brashear A, Kaelin D, McIntosh R, Liu J, Turkel C. The effect of repeated treatment of botulinum toxin type A on poststroke, spasticity-related pain: A subgroup analysis of patients in a 12-month trial. Neurology 2007;68(12 Suppl 1):A177 ABS-P04.131
• Elovic E, Brashear A, Kaelin D, McIntosh R, Liu J, Turkel C. Safety and efficacy of repeated botulinum toxin type A treatments for focal upper limb poststroke spasticity: Results of a 12-month multicenter, open-label trial. Neurotox Res 2006 Apr;9(2-3):230 ABS-P23

Helpful Links

• Link to Clinical Trial Results

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: April 1, 2008
• First Submitted That Met QC Criteria: April 1, 2008
• First Posted (Estimate): April 3, 2008

Study Record Updates

• Last Update Posted (Estimate): May 28, 2008
• Last Update Submitted That Met QC Criteria: May 23, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 191622-056