Two-year placebo-controlled trial of botulinum toxin A for leg spasticity in cerebral palsy

Abstract

There was no evidence of cumulative or persisting benefit from repeated botulinum toxin A (BtA) at the injection cycle troughs at 1 year or 2 years. The dose was not enough to change spasticity measures and thus GMFM in this heterogeneous group. Ceiling effects in GMFM and Pediatric Evaluation of Disability Index (PEDI) may have reduced responsiveness. This finding does not deny the value, individually, of single injection cycles or prove that repeating them is unhelpful. In this regard, BtA treatment can be viewed in the same light as other temporary measures to relieve spasticity, such as oral or intrathecal agents: there is no evidence of continuing benefit if the treatment ceases. The study provides long-term, fully controlled adverse event data and has not revealed any long-term adverse effects.

AbobotulinumtoxinA for Equinus Foot Deformity in Cerebral Palsy: A Randomized Controlled Trial

“…Doses were chosen on the basis of previous clinical studies 12,13 and are specific to abobotulinumtoxinA. Because of proprietary differences in manufacturing and assay procedures, potency units for abobotulinumtoxinA are not interchangeable with other BoNT-A products.…”

Practice Parameter: Pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review)

“…In contrast, 3 Class I placebo-controlled studies-(n ϭ 64), 22 (n ϭ 125), 30 and (n ϭ 52) 31 -using the same BoNT-A preparation at slightly higher dose (30 U/kg vs 25 U/kg) and the same outcome measure (GMFM) failed to demonstrate a significant functional improvement, despite significant improvements in ankle dorsiflexion 30 4 weeks after injections and initial foot contact 31 16 weeks after injections. Upper extremity functional improvement.…”

Estimation of botulinum toxin type A efficacy on spasticity and functional outcome in children with spastic cerebral palsy

“…It was noticed that younger children with I and II functional levels on GMFCS scale had higher consistent improvement, while older CP children with III and IV functional levels on the GMFCS scale had non significant improvements. One possible explanations could be the fact that children with moderate to severe physical limitations have lower potential for motoric functions improvement, with particular group at IV and V levels on the GMFCS scale, where limitation factor is contractures 24,25 . Our results were consistent with previous reports, pointing to the increase in motoric functions since the followed-up sample consisted of CP patients with functional levels from I to III.…”