Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
Overview
- Phase
- Phase 2
- Intervention
- botulinum toxin Type A
- Conditions
- Stroke
- Sponsor
- Allergan
- Enrollment
- 155
- Primary Endpoint
- Change From Baseline in Forced Vital Capacity (FVC)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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
Investigators
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
Arms & Interventions
1
Intervention: botulinum toxin Type A
2
Intervention: botulinum toxin Type A
3
Intervention: saline
Outcomes
Primary Outcomes
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 Outcomes
- Change From Baseline in FEV1/FVC Ratio(Baseline, Week 6)
- Change From Baseline in Ashworth Scale(Baseline, Week 6)