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

Phase 2

Completed

• Conditions: Stroke; Muscle Spasticity; Motor Neuron Disease
• Interventions: Biological: botulinum toxin Type A; Drug: saline

• Registration Number: NCT00076687
• Lead Sponsor: Allergan

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2004-01-29
• Study First Submitted QC: 2004-02-25
• Study First Posted: 2004-02-26
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2011-07-28
• Status Verified: 2011-08
• Results First Submitted QC: 2011-08-30
• Last Update Submitted: 2011-08-30
• Results First Posted: 2011-10-03
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	botulinum toxin Type A	-
2	botulinum toxin Type A	-
3	saline	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Forced Vital Capacity (FVC)	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)	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 Outcome Measures

Name	Time	Method
Change From Baseline in FEV1/FVC Ratio	Baseline, Week 6	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	Baseline, Week 6	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.