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news.Ipsen has reported the first set of results on Phase III clinical study of Dysport, an injectable form of botulinum toxin type A (BoNT-A), in the treatment of adults suffering from upper limb spasticity at the 8th World Congress for NeuroRehabilitation in Istanbul, Turkey.
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The Phase III research study was double blind, randomized, and placebo-controlled study designed to assess the efficacy of Dysport.. The study, which enrolled 243 patients, was conducted in the US, France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia and Hungary.
Results of the Phase III clinical study demonstrated that four weeks after Dysport injection, patients showed a statistically significantly higher proportion of responders in muscle tone improvement versus placebo point improvement as measured by the Modified Ashworth Scale.
Compared to 22.8% in the placebo arm, patients treated with Dysport 500 units and 1000 units showed responding rates of 73.8% and 78.5% at fourth week.
The Phase III clinical study results demonstrated that patients treated with Dysport showed a statistically significant higher clinical benefit versus placebo, as measured by the Physician Global Assessment (PGA).
Compared to 0.6 in the placebo arm, the mean PGA score for patients treated with Dysport 500 units and 1,000 units were 1.4 and 1.8 respectively at fourth week.
In addition, patients treated with Dysport showed a higher proportion of responders from baseline in improved passive function versus placebo.
At fourth week, patients treated with Dysport 1000 units showed a statistically significant response rate of 62%, while patients treated with Dysport 500 units showed a clinically relevant response rate of 50%. Placebo arm showed a 39% response rate.
According to Ipsen, safety profile observed in the study was consistent with the known safety profile of Dysport.
Ipsen chief scientific officer and R&D executive vice-president Claude Bertrand said the company is pleased that the first robust set of results from the phase III clinical study was presented by the Principal Investigator of the study (Dr JM Gracies) at this major congress.
"We look forward to sharing with the scientific community some additional data at coming international congresses," Bertrand added.
Dysport is approved for upper limb spasticity treatment in many international markets, but not in the US. In the US, the drug is only approved for therapeutic indication for the treatment of adults with cervical dystonia.