Abstract:
BACKGROUND:IncobotulinumtoxinA (Xeomin®) is a botulinum neurotoxin type A with established efficacy in the treatment of upper-limb spasticity in adults. This retrospective case series in a university hospital setting aimed to elucidate the safety and tolerability of incobotulinumtoxinA for treatment of spasticity in children with cerebral palsy. METHODS:Participants received incobotulinumtoxinA injections up to a maximum total dose of 600 U, 24 U/kg body weight. Medical records were reviewed for key demographic information, incobotulinumtoxinA exposure, and adverse effects (AEs). RESULTS:Sixty-nine children were included (mean age [SD], 8.3 [3.9] years; 44/69 [63.8%] male). One-hundred-and-ninety-one injections were administered, with mean (SD) of 2.8 (1.5) treatment cycles/participant and dosing interval of 6.0 (1.7) months. The number of muscles injected increased from 2.4 (1.2) at cycle 1 to 4.2 (1.9) at cycle 6. The mean (SD) total incobotulinumtoxinA dose increased from 191.7 (126.2) U, (8.5 [5.4] U/kg body weight) at cycle 1 to 368.0 (170.1) U, (9.9 [5.5] U/kg body weight) at cycle 6. Seventy four adverse effects (37.5% of injections) were reported, the most frequent was injection pain (93.2% of AEs). Only three AEs were considered directly treatment-related by injectors: muscle weakness, generalized weakness, and fever. CONCLUSIONS:Our clinical experience indicates that incobotulinumtoxinA is a well-tolerated treatment option for focal spasticity in children with cerebral palsy. TRIAL REGISTRATION:As the study was observational and retrospective, no EudraCT registration number was requested. The internal code assigned to the study in the administrative resolution was: 1143-N-15.
journal_name
BMC Neuroljournal_title
BMC neurologyauthors
León-Valenzuela A,Palacios JS,Del Pino Algarrada Rdoi
10.1186/s12883-020-01702-7subject
Has Abstractpub_date
2020-04-08 00:00:00pages
126issue
1issn
1471-2377pii
10.1186/s12883-020-01702-7journal_volume
20pub_type
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