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

Study Overview
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Brief Summary
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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

Conditions
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Stroke, Muscle Spasticity, Motor Neuron Disease

Intervention / Treatment
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* Biological: botulinum toxin Type A
* Biological: botulinum toxin Type A
* Drug: saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: botulinum toxin Type A<br>* botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18<br>* Other names: BOTOX®;|
| Experimental: 2<br> | Biological: botulinum toxin Type A<br>* botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18<br>* Other names: BOTOX®;|
| Placebo Comparator: 3<br> | Drug: saline<br>* Saline injection at Day 1, Week 12, Week 18<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 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. | Baseline, Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 6 | 
| 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. | Baseline, Week 6 |