Dysport phase III study results in children with cerebral palsy with lower limb spasticity published in Pediatrics

Jan 28 2016

Single injections of both Dysport^® (abobotulinumtoxinA) doses (10U/kg/leg and 15U/kg/leg) significantly reduce muscle hypertonia and spasticity translating into clinical and functional benefits

Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the scientific journal Pediatrics published the detailed results of the phase III randomized study (NCT01249417) showing both the efficacy and the safety of Dysport^® in the treatment of  dynamic equinus foot deformity (also known as pediatric lower limb spasticity), a condition associated with cerebral palsy in children.

The study met the primary endpoint (Modified Ashworth Scale, MAS) and the first secondary endpoint (Physician Global Assessment, PGA) in children with dynamic equinus foot deformity who received injections of Dysport^® in the gastrocnemius and soleus calf muscles. Dysport^® showed statistically significant improvement in muscle tone, resulting in an improved overall clinical benefit at week 4 at the two dose levels tested (10 and 15U/kg for unilateral injection or 20 and 30U/kg for bilateral injections). In addition, improvement of spasticity and attainment of overall treatment goals were demonstrated in a statistically and clinically significant manner as compared to placebo at week 4 after injection. Both doses of Dysport^® were well tolerated and there was no evidence of a dose relationship for adverse events. The most frequent treatment emergent adverse events were common childhood infections (upper respiratory tract infections).

Claude Bertrand, Executive Vice President R&D and Chief Scientific Officer, Ipsen stated:

The peer-reviewed publication of these Phase 3 results in the journal Pediatrics confirms the favorable efficacy and safety profile of Dysport^® in the treatment of lower limb spasticity in children with cerebral palsy and demonstrates improvement in functional benefit after a single injection of Dysport^®. The study results confirm the therapeutic value of Dysport^® in this debilitating condition, the most common cause of chronic motor disability in childhood.

Professor Mauricio Delgado, Director of the Pediatric Neurology Department at Texas Scottish Rite Hospital for Children and Professor of Neurology and Neurotherapeutics at the University of Texas Southwestern Medical Center and Principal Investigator of the study stated:

The publication of this study in Pediatrics is important news for the field of pediatric neurorehabilitation and for the treatment of children with equinus foot deformity due to cerebral palsy. This is the first international study that demonstrates substantial improvements in muscle tone and spasticity translating into clinical and functional benefits after a single injection in this patient population. This study both highlights the potential therapeutic value of Dysport^® (abobotulinum toxin) in children with cerebral palsy and shows the potential value of new assessment methods that could have practical clinical application.