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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00651729
First received: April 1, 2008
Last updated: May 23, 2008
Last verified: May 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Stroke
Muscle Spasticity
 Biological: Botulinum Toxin Type A
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Adverse events [ Time Frame: Week 54 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Spasticity as measured by the Ashworth scale [ Time Frame: Week 54 ] [ Designated as safety issue: No ]

Enrollment: 279
Study Start Date: April 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: BOTOX®

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651729

Locations
United States, Indiana
Indianapolis, Indiana, United States
Canada, British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Link to Clinical Trial Results  This link exits the ClinicalTrials.gov site

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
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

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00651729     History of Changes
Other Study ID Numbers: 191622-056
Study First Received: April 1, 2008
Last Updated: May 23, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Muscle Spasticity
Stroke
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013