A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury
Trial status: Open for Enrollment
Why is this study being done?
The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
Who is eligible to participate?
- Subjects aged 18 to 80 years of age
- Post stroke or brain injury
- Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
- Ambulatory patients
- Fixed contractures
- Physiotherapy initiated less than 4 weeks before entry
- Previous surgery or previous treatment with phenol and/or alcohol in lower limb
- Neurological/neuromuscular disorders which may interfere with protocol evaluations