Phase III trials of Dysport show response in Spasticity-Ipsen

Ipsen has announced topline results for two double-blind Phase III studies of Dysport (abobotulinumtoxinA) in pediatric lower limb (PLL) spasticity in children with cerebral palsy and in adult lower limb (ALL) spasticity in patients who had experienced a stroke or traumatic brain injury. In the PLL phase III study, conducted in children with hemiparetic or diplegic cerebral palsy, treatment with Dysport showed a statistically significant response versus placebo in the improvement of muscle tone, as measured by the Modified Ashworth Scale (MAS; primary endpoint), and a statistically significant overall benefit versus placebo, as measured by the Physician Global Assessment (PGA; secondary endpoint).

In the ALL phase III study, conducted in hemiparetic patients who had experienced a stroke or traumatic brain injury, treatment with Dysport at the dose of 1500U showed a statistically significant response versus placebo in the improvement of muscle tone, as measured by MAS. An overall benefit (measured by PGA) versus placebo was observed but did not reach statistical significance according to the pre-specified statistical analysis. Other spasticity and functional outcome results are currently being analyzed. The safety profile observed in the studies was consistent with the known safety profile of Dysport in these indications.