Safety profile of incobotulinum toxin A [Xeomin(®)] in gastrocnemious muscles injections in children with cerebral palsy: Randomized double-blind clinical trial.

BACKGROUND: The only two preparations of botulinum toxin A for which there are published evidences of efficacy in children with cerebral palsy are onabotulinum toxin A (Botox(®)) and abobotulinum toxin A (Dyport(®)); these toxins should be considered generally safe and appropriate in the treatment for localized upper and lower limb spasticity.

AIMS: To establish the safety profile of incobotulinum toxin A (Xeomin(®)) in children with cerebral palsy and muscle spasticity.

METHODS: Randomized double-blind controlled trial that involved the recruitment of children of both sexes with spastic hemiplegia or diplegia in cerebral palsy, aged between 3 and 18 years. Children were randomized to either the study group (SG, incobotulinum toxin A) or the control group (CG, onabotulinum toxin A) both to be injected with 5units/kg on gastrocnemius (medialis and lateralis) muscles. The occurrence of adverse events at baseline, after 48 h, 10 days and 3 months was recorded by the caregivers in a checklist that listed both common and uncommon side effects.

RESULTS: 35 patients were treated (CG = 18; SG = 17); the 2 groups were well balanced regarding demographics and anthropometry characteristics. At least 1 adverse event occurred in 49% of patients within first 2 days, 46% between 2 and 10 days, and 12% between 10 and 90 days. All the reported events were minor; no serious adverse event was recorded. Fatigue was the most frequent complaint. There was no significant difference in frequency and type of events between the 2 groups.

CONCLUSION: Incobotulinum toxin A and onabotulinum toxin A share similar profile of safety in the treatment of lower limb spasticity in CP children.