Ipsen Announces a first set of results on positive phase III clinical study of Dysport® in the treatment of adults suffering from Upper Limb Spasticity
- In adults with upper limb spasticity, treatment with Dysportdemonstrated improvement in muscle tone, clinical benefit and passive function.
- Four weeks after Dysportinjection, the Phase III clinical study results demonstrated that: Patients treated with Dysportshowed a statistically significantly (p<0.0001) higher proportion of responders in muscle tone improvement versus placebo (i.e. exhibiting =1 point improvement as measured by the Modified Ashworth Scale, MAS). At week 4, patients treated with Dysport500 units and 1000 units showed responding rates of 73.8% and 78.5%, respectively, compared to 22.8% in the placebo arm; Patients treated with Dysportshowed a statistically significant (p<0.0001) higher clinical benefit versus placebo, as measured by the Physician Global Assessment (PGA). At week 4, the mean PGA score for patients treated with Dysport500 units and 1000 units were 1.4 and 1.8, respectively, compared to 0.6 in the placebo arm.
- Additionally, patients treated with Dysportshowed 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 Dysport1000 units showed a statistically significant response rate of 62%. Patients treated with Dysport500 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.