Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | February 2014 |
Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb
The purpose of this study is to determine whether injections of Botulinum toxin type A into
muscles of the upper limb are effective in treating spasticity in patients after stroke.
muscles of the upper limb are effective in treating spasticity in patients after stroke.
The study consists of a randomized, double-blind, placebo-controlled, parallel-group,
single-dose main period followed by an open-label, non-controlled, repeated-dose extension
period (Open-Label Extension Period - OLEX).
single-dose main period followed by an open-label, non-controlled, repeated-dose extension
period (Open-Label Extension Period - OLEX).
Inclusion Criteria:
- Upper limb spasticity
- Time since stroke greater than 3 months
- Need for 400 U Botulinum toxin type A
Exclusion Criteria:
- Body weight below 50kg
- Fixed contractures of the upper limb
- Generalized disorders of muscle activity like Myasthenia gravis that preclude use of
Botulinum toxin Type A
- Infection at the injection site
We found this trial at
14
sites
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