Phase III trial with Dysport shows benefits for patients with Upper Limb Spasticity - Ipsen

Ipsen has announced a first set of results on Phase III clinical study of Dysport in the treatment of adults suffering from Upper Limb Spasticity. Four weeks after Dysport injection, the Phase III clinical study results demonstrated that patients treated with Dysport showed a statistically significantly higher proportion of responders in muscle tone improvement versus placebo. At week 4, patients treated with Dysport 500 units and 1000 units showed responding rates of 73.8% and 78.5%, respectively, compared to 22.8% in the placebo arm. Additionally, patients treated with Dysport showed a statistically significant higher clinical benefit versus placebo, as measured by the Physician Global Assessment (PGA).

At week 4, the mean PGA score for patients treated with Dysport 500 units and 1000 units were 1.4 and 1.8, respectively, compared to 0.6 in the placebo arm. Patients also showed a higher proportion of responders from baseline in improved passive function versus placebo. 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. Data were presented at the 8th World Congress for NeuroRehabilitation.