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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:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00076687
First received: January 29, 2004
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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:
  • Change From Baseline in Forced Vital Capacity (FVC) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00076687     History of Changes
Other Study ID Numbers: 191622-057
Study First Received: January 29, 2004
Results First Received: July 28, 2011
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Muscle Spasticity
Stroke
Cerebral Infarction
Motor Neuron Disease
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
Brain Infarction
Brain Ischemia
Neurodegenerative Diseases
Neuromuscular 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 May 19, 2013