Irish Medicines Board recommends Botox for Spasticity after Stroke-Allergan
Allergan has announced that Botox (botulinum type A) has received a positive opinion from the Irish Medicines Board serving as reference member state in the mutual recognition procedure (MRP) for the treatment of focal Spasticity of the ankle in adult post Stroke patients.
This positive opinion is based on a Phase III, multi-centre, randomised, double-blind, placebo-controlled study, assessing the efficacy and safety of Botox in patients with post-stroke lower limb spasticity affecting the ankle. A total of 120 patients were randomised to a single treatment of Allergan's Botulinum toxin type A (300 Units) or placebo.
Results from the study showed patients treated with Botulinum toxin type A achieved a significant improvement in muscle tone compared to those treated with placebo. Significant improvements compared to placebo were also observed at the individual post-treatment visits at weeks 4, 6 and 8. Finally Botulinum toxin type A treatment was associated with a significant improvement in the investigator's clinical global impression (CGI) of functional disability compared to placebo at weeks 4, 6 and 8.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins