Ipsen: Treatment With Dysport Improved Muscle Tone In Cerebral Palsy Children

Posted: Published on January 26th, 2015

This post was added by Dr Simmons

By RTT News, January 26, 2015, 01:42:00 AM EDT

(RTTNews.com) - Ipsen SA ( IPSEY ) Monday reported topline results for two double-blind phase III studies of Dysport (abobotulinumtoxinA) in Pediatric Lower Limb or PLL spasticity in children with cerebral palsy and in Adult Lower Limb or 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 compared to placebo in the improvement of muscle tone, as measured by the Modified Ashworth Scale or MAS, which was the primary endpoint. It also showed a statistically significant overall benefit versus placebo, as measured by the Physician Global Assessment or PGA, which was the first 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.

The safety profile observed in the studies was consistent with the known safety profile of Dysport in these indications.

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Ipsen: Treatment With Dysport Improved Muscle Tone In Cerebral Palsy Children

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