Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | December 2011 |
| End Date: | May 2015 |
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 Lower Limb
The purpose of this study is to determine whether injections of Botulinum toxin type A into
muscles of the leg are effective in treating patients with increased muscle
tension/uncontrollable muscle stiffness (spasticity) after a stroke.
muscles of the leg are effective in treating patients with increased muscle
tension/uncontrollable muscle stiffness (spasticity) after a stroke.
Inclusion Criteria:
- Age from 18-80 yrs
- Lower 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 lower 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
13
sites
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