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Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00076687
First Posted: February 26, 2004
Last Update Posted: October 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity

Condition Intervention Phase
Stroke Muscle Spasticity Motor Neuron Disease Biological: botulinum toxin Type A Drug: saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Forced Vital Capacity (FVC) [ Time Frame: Baseline, Week 6 ]
    Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.

  • Change From Baseline in Forced Expiratory Volume (FEV1) [ Time Frame: Baseline, Week 6 ]
    Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.


Secondary Outcome Measures:
  • Change From Baseline in FEV1/FVC Ratio [ Time Frame: Baseline, Week 6 ]
    Change from baseline in FEV1/FVC ratio. This ratio is calculated by dividing the FEV1 value by the FVC value. This represents that portion (or ratio) of FVC exhaled in one second.

  • Change From Baseline in Ashworth Scale [ Time Frame: Baseline, Week 6 ]
    Change from Baseline in worst upper limb scores using the Ashworth Scale at Week 6 from Baseline. Upper limb includes finger, wrist, thumb, and elbow. Worst score was the highest value measured from the finger, wrist, thumb, or elbow at Baseline and Week 6 based on treated areas. The Ashworth Scale assesses the degree of muscle tone. It is a 5-point scale where 0 equals no increase in muscle tone and 4 equals very severe muscle rigidity. A low score indicates little or no stiffness. A high score indicates severe stiffness. A negative change from baseline score indicates improvement.


Enrollment: 155
Study Start Date: October 2003
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: botulinum toxin Type A
botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18
Other Name: BOTOX®
Experimental: 2 Biological: botulinum toxin Type A
botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18
Other Name: BOTOX®
Placebo Comparator: 3 Drug: saline
Saline injection at Day 1, Week 12, Week 18

  Eligibility

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
Criteria

Inclusion Criteria:

  • Abnormal pulmonary function test results;
  • focal, upper limb spasticity, upper motor neuron syndrome

Exclusion Criteria:

  • Previous exposure to botulinum toxin of any serotype
  Contacts and Locations
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): NCT00076687


Locations
United States, Florida
Miami, Florida, United States
Czech Republic
Prague, Czech Republic
Hungary
Szeged, Hungary
Poland
Warsaw, Poland
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00076687     History of Changes
Other Study ID Numbers: 191622-057
First Submitted: January 29, 2004
First Posted: February 26, 2004
Results First Submitted: July 28, 2011
Results First Posted: October 3, 2011
Last Update Posted: October 3, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Stroke
Motor Neuron Disease
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
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