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Ipsen SA announces positive initial results from the international double-blind clinical phase III study of Dysport in the treatment of adults suffering from upper limb spasticity


Tuesday, 17 Dec 2013 01:00am EST 

Ipsen SA:Says positive initial results from the double-blind phase III study of Dysport (abobotulinumtoxinA) in Adult Upper Limb spasticity.Says regarding the primary endpoints, treatment with Dysport showed statistically significant response versus placebo in the improvement of muscle tone, as measured by the Modified Ashworth Scale (MAS).Says in addition, a statistically significant clinical benefit for the patients treatei with Dysport was demonstrated versus placebo, as measured by the Physician Global Assessment (PGA).Says the safety profile observed in the study was consistent with the known safety profile of Dysport in this indication.Says comprehensive results from this double-blind study will be disclosed in the next few months at major international congresses.Says this phase III research study included 243 patients and was multicentric, prospective, double blind, randomised, and placebo-controlled. It was conducted in the USA, France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia and Hungary.Says the purpose of this study was to assess the efficacy of Dysport compared to placebo in improving upper limb spasticity in hemiparetic patients following a stroke or a brain trauma.Says the study co-primary endpoints were the improvement of muscle tone in the treated upper limb measured by the Modified Ashworth Scale (MAS) and the clinical benefit for the patients assessed by the Physician Global Assessment (PGA). 

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