Efficacy of Repeat AbobotulinumtoxinA (Dysport®) Injections in Improving Gait in Children with Spastic Cerebral Palsy.

Abstract

Purpose: This secondary analysis of a randomized, double-blind study plus open-label extension (NCT01249417/NCT01251380) evaluated the efficacy of abobotulinumtoxinA versus placebo in improving gait pattern in children with dynamic equinus due to cerebral palsy (CP) as assessed by the observational gait scale (OGS). Methods: Ambulatory children with CP (N = 241, aged 2-17) and dynamic equinus were randomized to treatment with abobotulinumtoxinA (10 or 15U/kg/leg) or placebo injected into the gastrocsoleus. All children received abobotulinumtoxinA in the open-label phase. Results: In the double-blind phase, abobotulinumtoxinA significantly improved OGS total scores versus placebo at Week 4 (treatment effect vs. placebo: 10U/kg/leg: 1.5 [0.7, 2.3], p = .0003; 15U/kg/leg: 1.1 [0.3, 1.9], p = .01). In the open-label phase, treatment with abobotulinumtoxinA continued to improve the OGS score at the same magnitude as seen in the double-blind study. Conclusion: Repeat treatment with abobotulinumtoxinA improved gait in children with dynamic equinus.

• Authors: Nigar Dursun, Marcin Bonikowski, Edward Dabrowski, Dennis Matthews, Mark Gormley, Ann Tilton, Jorge Carranza, Anne-Sophie Grandoulier, Philippe Picaut, Mauricio R Delgado
• Journal: Developmental neurorehabilitation (Dev Neurorehabil) Vol. 23 Issue 6 Pg. 368-374 (Aug 2020) ISSN: 1751-8431 [Electronic] England
• PMID: 31691605 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A
• abobotulinumtoxinA

Topics

• Adolescent
• Botulinum Toxins, Type A (administration & dosage, adverse effects, therapeutic use)
• Cerebral Palsy (drug therapy, rehabilitation)
• Child
• Child, Preschool
• Double-Blind Method
• Drug Administration Schedule
• Female
• Gait
• Humans
• Injections, Intramuscular
• Male
• Neuromuscular Agents (administration & dosage, adverse effects, therapeutic use)