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Good Results for Dysport in Spasticity Trial

Ipsen botulinum toxin performs well against Adult Upper Limb spasticity

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Ipsen has posted positive initial results from the Phase III study of Dysport (abobotulinumtoxinA) in Adult Upper Limb spasticity. 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). In addition, a statistically significant clinical benefit for the patients treated with Dysport was demonstrated versus placebo, as measured by the Physician Global Assessment (PGA). The safety profile observed in the study was consistent with the known safety profile of Dysport in this indication. Comprehensive results from this double-blind study will be disclosed in the next few months at international congresses.

The multicentric, prospective, double-blind, randomized, and placebo-controlled trial included 243 patients and was conducted in the U.S., France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia and Hungary. The study was designed to assess the efficacy of Dysport compared to placebo in improving upper limb spasticity in hemiparetic patients following a stroke or a brain trauma. Patients were offered to continue in an open label long-term study wherein they will be receiving additional Dysport® treatment cycles within a total of 15 months.

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