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

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ClinicalTrials.gov Identifier: NCT00651690
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : May 28, 2008
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Brief Summary:
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 or disease Intervention/treatment Phase
Stroke Muscle Spasticity Biological: Botulinum Toxin Type A Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2004
Primary Completion Date : May 2005
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Spasticity of the upper-limb flexors as measured by the Ashworth Scale [ Time Frame: Week 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651690

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

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.
ClinicalTrials.gov Identifier: NCT00651690     History of Changes
Other Study ID Numbers: 191622-065
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: May 28, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents