Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
Information source: Allergan
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke; Muscle Spasticity; Motor Neuron Disease
Intervention: botulinum toxin Type A (Biological); botulinum toxin Type A (Biological); saline (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Overall contact:
Allergan Inc., Email: clinicaltrials@allergan.com
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
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Primary outcome: Forced expiratory volumeForced vital capacity
Secondary outcome: Spasticity of affected flexor muscles (Ashworth scale)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Allergan Inc., Email: clinicaltrials@allergan.com
Prague, Czech Republic; Recruiting
Szeged, Hungary; Recruiting
Warsaw, Poland; Enrolling by invitation
Miami, Florida, United States; Recruiting
Additional Information
Starting date: October 2003
Ending date: December 2009
Last updated: December 5, 2008
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