The principal investigator (PI) for a randomized controlled trial of Basking Ridge, NJ-based Ipsen Biopharmaceutical’s Dysport on September 22 reported extension study data on the botulinum toxin type A (ABO) for pediatric patients with cerebral palsy (CP) at the American Academy of Cerebral Palsy and Developmental Medicine annual meeting in Hollywood, FL.
Study PI Mauricio Delgado, MD, director of the Texas Scottish Rite Hospital for Children in Dallas, shared results of the open-label extension study (up to four additional injections) following the phase 3 trial of Dysport in 235 pediatric patients aged 2 to 17 years with dynamic equinus due to CP.
Researchers measured mean change in Modified Ashworth scale (MAS) and mean Physician’s Global Assessment (PGA) response to treatment. Both parameters improved significantly at four and 12 weeks; 207 patients opted to enter the extension study and received at least one ABO injection.
Most (99.6%) patients had injections to the gastrocsoleus complex, 17% to 24% of patients had hamstrings injections, and 11% to 12% patients had injections into other lower limb muscles.
Mean change in MAS scores from baseline to week 4 were: -1 (n = 170), -1.1 (n = 122) and -1 (n = 66) in cycles one, two, and three, respectively. Mean week four PGA scores were 1.5 (n = 195), 1.5 (n = 159), and 1.4 (n = 78), respectively. Patients who received ABO vs placebo also significantly improved muscle tone in the knee flexors (mean change in MAS scores ranged from -.2 to -.8 across cycles).