Safety and Efficacy of Repeat Open-Label AbobotulinumtoxinA Treatment in Pediatric Cerebral Palsy.

Abstract

This was a prospective, repeat-treatment, open-label study (NCT01251380) of abobotulinumtoxinA for the management of lower limb spasticity in children who had completed a double-blind study. Children (2-17 years) received injections into the gastrocnemius-soleus complex, and other distal and proximal muscles as required (maximum total dose per injection cycle: 30 U/kg or 1000U). A total of 216 of the 241 double-blind patients entered the extension study and 207 received ≥1 open label injection into the gastrocnemius-soleus; 17-24% of patients also had injections into the hamstrings. The most frequent adverse events were related to common childhood infections and the most frequent treatment-related adverse event was injection site pain (n = 10). There was no evidence of a cumulative effect on adverse events. Sustained significant clinical improvements in muscle tone (Modified Ashworth Scale), spasticity (Tardieu Scale), overall clinical benefit (Physicians Global Assessment), and goal attainment (Goal Attainment Scale) were also observed across treatment cycles.

• Authors: Mauricio R Delgado, Marcin Bonikowski, Jorge Carranza, Edward Dabrowski, Dennis Matthews, Barry Russman, Ann Tilton, Juan Carlos Velez, Anne-Sophie Grandoulier, Philippe Picaut
• Journal: Journal of child neurology (J Child Neurol) Vol. 32 Issue 13 Pg. 1058-1064 (Nov 2017) ISSN: 1708-8283 [Electronic] United States
• PMID: 28914131 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Observational Study, Randomized Controlled Trial)

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A
• abobotulinumtoxinA

Topics

• Adolescent
• Botulinum Toxins, Type A (adverse effects, therapeutic use)
• Cerebral Palsy (drug therapy, physiopathology)
• Child
• Child, Preschool
• Female
• Humans
• Lower Extremity (physiopathology)
• Male
• Muscle Spasticity (drug therapy, physiopathology)
• Muscle, Skeletal (drug effects, physiopathology)
• Neuromuscular Agents (adverse effects, therapeutic use)
• Paresis (drug therapy, physiopathology)
• Severity of Illness Index
• Treatment Outcome