drugset / Trial / NCT00945295
Efficacy and Safety Study of Botulinum Neurotoxin A With Rehabilitation Versus Botulinum Neurotoxin A Alone in Treatment of Post-stroke Spasticity
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if a combination of botulinum neurotoxin A and rehabilitation therapy is better than botulinum neurotoxin A alone for improvement in function based on the Fugl-Meyer and other validated measures. Hypothesis: The combination of botulinum neurotoxin A and rehabilitation therapy will produce better functional improvement than botulinum neurotoxin A alone in post-stroke upper limb spasticity measured by the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke.
Timeline
- Start
- 2009-01
- Primary completion
- 2012-05
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 6 iu/kg | Intramuscular |
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 200 iu | Intramuscular |
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 400 iu | Intramuscular |
Indications
No indication recorded.