Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment

This study has been completed.
Information provided by:
Allergan Identifier:
First received: April 1, 2008
Last updated: May 23, 2008
Last verified: May 2008
This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A treatment in poststroke patients with spasticity of the upper-limb flexors

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Seven functional tasks (nail filing, hand cleaning, holding a water bottle, brushing teeth, holding a small fruit, holding a medium fruit, and holding a large fruit) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spasticity of the upper-limb flexors as measured by the Ashworth Scale [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: March 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Botulinum Toxin Type A
Biological: Botulinum Toxin Type A
200 U to 360 U of botulinum toxin Type A on Day 0. Patients who met retreatment criteria received a second treatment (open-label) at Week 12 or Week 18
Other Name: BOTOX®
Placebo Comparator: 2
Biological: Placebo
Saline injection on Day 0


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Medically stable poststroke with focal unilateral upper-limb spasticity

Exclusion Criteria:

  • Stroke within 6 months of the study enrollment visit
  • Previous or current botulinum toxin therapy of any type in the study limb
  Contacts and Locations
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Please refer to this study by its identifier: NCT00651690

United States, Indiana
Indianapolis, Indiana, United States
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Turkel C, Bowen B, Liu J, Brin M. A pooled analysis of the safety of BoNTA (BOTOX(R)) in the treatment of poststroke spasticity. Neurorehabil Neural Repair 2006;20(1):200 ABS-P3-081
Turkel C, Bowen B, Liu J, Brin M. A pooled analysis of the safety of BoNT-A (BOTOX(R)) in the treatment of poststroke spasticity. Neurotox Res 2006 Apr;9(2-3):230 ABS-P25

Responsible Party: Therapeutic Area Head, Allergan, Inc. Identifier: NCT00651690     History of Changes
Other Study ID Numbers: 191622-065 
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
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 03, 2016