Back to resultsSafety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
Primary Purpose
Stroke, Muscle Spasticity, Motor Neuron Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
botulinum toxin Type A
botulinum toxin Type A
saline
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Forced Vital Capacity (FVC)
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)
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00076687
Brief Title
Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Muscle Spasticity, Motor Neuron Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
BOTOX®
Intervention Description
botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
BOTOX®
Intervention Description
botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
Saline injection at Day 1, Week 12, Week 18
Primary Outcome Measure Information:
Title
Change From Baseline in Forced Vital Capacity (FVC)
Description
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.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Forced Expiratory Volume (FEV1)
Description
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.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in FEV1/FVC Ratio
Description
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.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Ashworth Scale
Description
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.
Time Frame
Baseline, Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Miami
State/Province
Florida
Country
United States
City
Prague
Country
Czech Republic
City
Szeged
Country
Hungary
City
Warsaw
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
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