At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 155 enrolled
Drug / intervention
botulinum toxin Type A +2 morebiological
Likely dose
Botulinum toxin Type A 240 U or 360 U by injection at Day 1, Week 12, and Week 18AI-extracted
Key inclusion· 2
- ✓Abnormal pulmonary function test results
- ✓Focal, upper limb spasticity from upper motor neuron syndrome
Key exclusion· 1
- ✕Prior exposure to botulinum toxin of any serotype
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
In Brief
A Phase 2 clinical trial evaluating botulinum toxin Type A and saline for Stroke and 2 related conditions. Completed, enrolled 155 participants across 4 sites in 4 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Muscle Spasticity, Motor Neuron Disease
CountriesCzechia, Hungary, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2003
First PostedFeb 2004
Primary CompletionAug 2009
TodayJul 2026
First PostedFeb 26, 2004
Enrollment StartOct 1, 2003
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 22.3 years ago
Interventions
botulinum toxin Type Abiological
botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18
botulinum toxin Type Abiological
botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18
salinedrug
Saline injection at Day 1, Week 12, Week 18