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

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076687
• Other study ID #: 191622-057
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2004
• Last updated: August 30, 2011
• Start date: October 2003
• Est. completion date: August 2009

Study information

• Verified date: August 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Motor Neuron Disease
• Muscle Spasticity
• Stroke

Intervention

Biological:
• botulinum toxin Type A
botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18
• botulinum toxin Type A
botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18

Drug:
• saline
Saline injection at Day 1, Week 12, Week 18

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Czech Republic,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No