drugset / Trial / NCT00432666

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb

NCT00432666 ↗

Phase 3 Completed 148 enrolled Merz Pharmaceuticals GmbH
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

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 400 iu Intramuscular