Ipsen announced that a first set of results on Phase 3 clinical study of Dysport in the treatment of adults suffering from Upper Limb Spasticity was presented on Saturday at the 8th World Congress for NeuroRehabilitation in Istanbul (Turkey).
Claude Bertrand, executive vice president of research & development and chief scientific officer at Ipsen, commented: “We are pleased that the first robust set of results from the Phase 3 clinical study was presented by the Principal Investigator of the study 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 3 clinical study results demonstrated that:
- Patients treated with Dysport showed 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 four, patients treated with Dysport 500 units and 1,000 units showed responding rates of 73.8% and 78.5%, respectively, compared to 22.8% in the placebo arm;
- Patients treated with Dysport showed 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 Dysport 500 units and 1000 units were 1.4 and 1.8, respectively, compared to 0.6 in the placebo arm.
Additionally, patients treated with Dysport showed a higher proportion of responders from baseline in improved passive function versus placebo. At week four, 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.
Dysport is approved for the treatment of upper limb spasticity in many international markets, but not in the United States (US). Dysport’s only approved therapeutic indication in the United States 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 United States.
Date: April 12, 2014