drugset / Trial / NCT00432666
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb
RandomizedParallel-groupQuadruple-blindTreatment
Summary
IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the upper limb.
Timeline
- Start
- 2006-06
- Primary completion
- 2006-11
- Completion
- 2008-05
Outcome
Met primary endpoint
registry analysis (superiority or other test); incobotulinumtoxinA (Xeomin) vs Placebo; p <0.001; Odds Ratio (OR) 3.97 (95% CI 1.90 to 8.30); Regression, Logistic NCT00432666 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 400 iu | Intramuscular |