Ipsen announces additional Phase III study results for Dysport
Posted: 23 October 2015 |
The Phase III study evaluated the investigational use of Dysport for the treatment of spastic equinus foot, a condition associated with cerebral palsy in children aged 2-17…
Ipsen has announced additional results from a Phase III study evaluating the investigational use of Dysport for the treatment of spastic equinus foot, a condition associated with cerebral palsy in children aged 2-17.
The study evaluated the efficacy and safety of Dysport versus placebo on the mean change from baseline in ankle joint hypertonicity in 241 children with cerebral palsy. The primary endpoint was the change in Modified Ashworth Scale (MAS) from baseline to Week 4. At Week 4, muscle tone was improved with Dysport as measured by the primary endpoint, the Modified Ashworth Scale (MAS).
Selected secondary endpoints for the study were the mean Goal Attainment Scale (GAS) score at Week 4. 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 Dysport showed higher goal achievement than the expected score of 50, whereas patients on placebo did not reach the expected level.
Largest clinical trial of a botulinum toxin in children with cerebral palsy
Claude Bertrand, Executive Vice-President Research & Development and Chief Scientific Officer of Ipsen commented: “These results evaluate the efficacy of Dysport on both spasticity and function after a single injection in children with lower limb spasticity due to cerebral palsy. Ipsen is committed to developing new alternatives for the treatment of spasticity in children.”
“We are encouraged by the most recent study results evaluating the efficacy and safety of Dysport in children with spastic equinus foot deformity due to cerebral palsy” said Mauricio Delgado, MD, FAAN, FRCPC, Director of Pediatric Neurology, Texas Scottish Rite Hospital for Children, Professor at University of Texas Southwestern Medical Center at Dallas. “To date, this is the largest enrolled and completed clinical trial of a botulinum toxin for a population of children with cerebral palsy.”
Dysport is approved for the treatment of paediatric lower limb spasticity in many European and international markets, but not currently in the United States.