Ipsen Biopharmaceuticals reported additional results from an extended clinical trial evaluating the safety and effectiveness of Dysport (botulinum toxin type A) in children with lower limb spasticity due to cerebral palsy at this year’s meeting of the American Academy of Cerebral Palsy and Developmental Medicine Sept. 20-24 in Hollywood, Florida.
The presentation, “Safety And Efficacy Of Repeated Dosing Of Abobotulinumtoxina (Dysport) In Children With Lower Limb Spasticity Due To Cerebral Palsy,” was conducted by Dr. Mauricio Delgado, director of the Texas Scottish Rite Hospital.
Pediatric lower limb spasticity is a neurological condition that commonly affects children with cerebral palsy, and is characterized by damage in the neurons that control muscle movement or posture. The symptoms include increased muscle tone or stiffness in one or more muscles, rapid muscular contractions, and muscle spasms.
Dysport is an injectable form of botulinum toxin type A, a molecule produced by the bacteria Clostridium botulinum. While it has a very potent effect with adverse effects in infections, this toxin, when applied in small amounts, can be used to treat several disorders related to excessive muscle activation by relaxing the muscles near the injection site.
“We are pleased to present this data … following the FDA’s recent approval of Dysport for the treatment of lower limb spasticity in pediatric patients aged 2 and older,” Cynthia Schwalm, executive vice president of Ipsen’s North America Commercial Operations, said in a news release. “Ipsen is committed to fully exploring the role that Dysport can play in helping meet the needs of children with lower limb spasticity.”
The results come from an open-label extension study of four additional treatment sessions following the Phase 3 trial (NCT01249417) conducted in five countries evaluating the safety and effectiveness of Dysport in 235 pediatric patients ages 2-17, of whom 158 received the treatment and 77 received a placebo.
The researchers assessed the effectiveness of Dysport by analyzing two parameters: the mean change in the Modified Ashworth scale (MAS) in the muscle tone of the ankle plantar flexor, and the mean Physician’s Global Assessment (PGA) response to treatment.
Results showed that both parameters were significantly improved after weeks 4 and 12 of the trial. Patients who were retreated at weeks 12 through 28 completed the study, and were able to enter the enxtension study if they wished.
The results supported the approval of Dysport as the first treatment based on the botulinum toxin by the FDA for pediatric lower limb spasticity.
The drug can also be used in adults with upper limb spasticity (to decrease the severity of increased muscle tone in the elbows, wrists and finger flexors) and in adults with cervical dystonia, but it is not known whether it can also improve lower limb spasticity in adults.
Similarly, the safety and effectiveness of Dysport is unknown in children younger than 2 with lower limb spasticity. A clinical trial is currently ongoing for Dysport in children with upper limb spasticity to evaluate the drug’s safety and effectiveness (NCT02106351).
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