French drugmaker Ipsen (Euronext: IPN) has announced positive initial results from a Phase III study of Dysport (abobotulinumtoxin A) in adult upper limb spasticity.
The Phase III double blind, randomized, and placebo-controlled study included 243 patients across the USA, France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia and Hungary. The aim 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. Treatment with Dysport showed statistically-significant response versus placebo in the improvement of muscle tone, as measured by the Modified Ashworth Scale (MAS). A statistically significant clinical benefit was also demonstrated versus placebo, as measured by the Physician Global Assessment (PGA).
Marc de Garidel, chairman and chief executive of Ipsen,stated: “These clinical results are an important step in our ambition to become a global leader in the treatment of targeted debilitating diseases. Expanding our scope of indications for Dysport would help us further develop the neurology franchise, notably in the USA.”
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