Phase III results for Dysport Next Generation in Cervical Dystonia-Ipsen
Ipsen has announced the results of the international Phase III clinical trial of Dysport Next Generation (DNG) in Cervical Dystonia. DNG was clinically and statistically superior to placebo in the Cervical Dystonia Phase III study at the dose of 500 units at week 4 after single dose (adjusted mean reduction of 12.5 with DNG. versus 3.9 with placebo as assessed by the Toronto Western Spasmodic Torticollis Rating Scale, or TWSTRS, total score). When compared to Dysport, DNG did not demonstrate the statistical non-inferiority in efficacy at week 4 (adjusted mean reduction of 12.5 with DNG versus 14.0 with Dysport in TWSTRS total score). This efficacy difference is unlikely to be of clinical relevance.
After repeated dose, DNG showed comparable efficacy to that of Dysport as observed in former Phase III studies.
In the cervical dystonia Phase III study, DNG was shown as significantly superior to placebo. Non-inferiority versus Dysport at week 4 was not demonstrated.
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