Ipsen announces a first set of results on positive phase III clinical study of Dysport in the treatment of adults …

Claude Bertrand, Executive Vice-President Research & Development and Chief Scientific Officer of Ipsen, commented: We are pleased that the first robust set of results from the phase III clinical study was presented by the Principal Investigator of the study (Pr JM Gracies) at this major congress. We look forward to sharing with the scientific community some additional data at coming international congresses.

Four weeks after Dysport injection, the Phase III clinical study results demonstrated that:

Additionally, patients treated with Dysport showed a higher proportion of responders from baseline in improved passive function versus placebo (exhibiting 1 grade decrease as measured by the disability assessment scale). At week 4, patients treated with Dysport 1000 units showed a statistically significant response rate of 62%. Patients treated with Dysport 500 units showed a clinically relevant response rate of 50%. Placebo arm showed a 39% response rate.

The safety profile observed in the study was consistent with the known safety profile of Dysport.

Further results from this double-blind study will be disclosed in the next few months at major international congresses.

For more detailed information about the 8th World Congress for NeuroRehabilitation, please see http://www.wcnr2014.org

Dysport is approved for the treatment of upper limb spasticity in many international markets, but not in the United States (US). Dysports only approved therapeutic indication in the United States (US) is for the treatment of adults with cervical dystonia (referred to spasmodic torticollis in other markets). As such, data from this study in adults with upper limb spasticity are with respect to an investigational use of Dysport in the USA.

About the study

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.

The purpose of this phase III 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. 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). In addition, Dysports efficacy was assessed on passive function as measured by the Disability Assessment Scale (DAS).

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Ipsen announces a first set of results on positive phase III clinical study of Dysport in the treatment of adults ...