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.

First Received: April 1, 2008 Last Updated: May 23, 2008 History of Changes

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00651690

Purpose

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
Stroke Muscle Spasticity	Biological: Botulinum Toxin Type A Biological: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

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
1: Experimental 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
2: Placebo Comparator Saline	Biological: Placebo Saline injection on Day 0

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651690

Locations

United States, Indiana

Indianapolis, Indiana, United States

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:

Turkel CC, Bowen B, Liu J, Brin MF. Pooled analysis of the safety of botulinum toxin type A in the treatment of poststroke spasticity. Arch Phys Med Rehabil. 2006 Jun;87(6):786-92.

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:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-065
Study First Received:	April 1, 2008
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00651690 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Muscle Spasticity
Botulinum Toxins
Muscular Diseases
Musculoskeletal Diseases
Cerebral Infarction

Muscle Hypertonia
Stroke
Neurologic Manifestations
Peripheral Nervous System Agents
Botulinum Toxin Type A

Additional relevant MeSH terms:

Neuromuscular Manifestations
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Neuromuscular Agents
Pharmacologic Actions
Signs and Symptoms
Muscle Spasticity
Muscular Diseases

Botulinum Toxins
Musculoskeletal Diseases
Muscle Hypertonia
Therapeutic Uses
Neurologic Manifestations
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009