New results from Phase III study of Dysport (abobotulinumtoxinA) in spastic equinus foot- Ipsen Biopharmaceuticals

Ipsen Biopharmaceuticals announced results from a Phase III study (NCT01249417) evaluating the investigational use of Dysport (abobotulinumtoxinA) for injection in the treatment of spastic equinus foot, a condition associated with cerebral palsy (CP) in children aged 2–17. This global, multicentre, double-blind, randomised, placebo-controlled study evaluated the efficacy and safety of abobotulinumtoxinA (ABO) versus placebo on the mean change from baseline in ankle joint hypertonicity in 241 children with cerebral palsy. At Week 4, muscle tone was improved with ABO as measured by the primary endpoint, the Modified Ashworth Scale (MAS). In the intention to treat population, the adjusted least squares mean changes in the MAS score from baseline to Week 4 showed statistically significant differences in favour of the ABO 10U/kg/leg treatment group and the ABO 15U/kg/leg treatment group vs placebo. Treatment-related adverse events occurred in 8.9% of the placebo group, 7.5% in the ABO 10U/kg/leg group, and 6.3% in the the ABO 15U/kg/leg treatment.

Data presented also included the secondary endpoint of Goal Attainment Scale (GAS). In this study, the most frequently chosen goals were improved walking pattern (70.2% of patients), improved balance (32.3%), and decreased falling (31.1%). As measured by the GAS, where a score of 50 represents goal achieved as expected, patients with ABO showed higher goal achievement than the expected score of 50 (GAS of 50.9 for 15U/kg and 51.5 for 10U/kg), whereas patients on placebo did not reach the expected level (GAS score of 46.2). Treatment effects for GAS were significant for both ABO groups versus placebo. The data will be presented at the 69th Annual Meeting of the American Academy for Cerebral Palsy and Developmental Medicine.