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

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT00076687

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 II

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

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

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 February 09, 2012