PMID- 32268880
OWN - NLM
STAT- MEDLINE
DCOM- 20200907
LR  - 20200907
IS  - 1471-2377 (Electronic)
IS  - 1471-2377 (Linking)
VI  - 20
IP  - 1
DP  - 2020 Apr 8
TI  - IncobotulinumtoxinA for the treatment of spasticity in children with cerebral 
      palsy - a retrospective case series focusing on dosing and tolerability.
PG  - 126
LID - 10.1186/s12883-020-01702-7 [doi]
LID - 126
AB  - BACKGROUND: IncobotulinumtoxinA (Xeomin(R)) 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.
FAU - Leon-Valenzuela, Angel
AU  - Leon-Valenzuela A
AD  - Unidad de Gestion Clinica de Rehabilitacion, Hospital Puerto Real, Puerto Real, 
      Cadiz, Spain. angel.leon.valenzuela@gmail.com.
AD  - Grupo iRehab, Instituto de Investigacion e Innovacion Biomedica de Cadiz, Cadiz, 
      Spain. angel.leon.valenzuela@gmail.com.
AD  - Departamento Materno-Infantil, Facultad de Medicina, Universidad de Cadiz, Cadiz, 
      Spain. angel.leon.valenzuela@gmail.com.
FAU - Palacios, Juan Sanchez
AU  - Palacios JS
AD  - Unidad de Gestion Clinica de Rehabilitacion, Hospital Puerta del Mar, Cadiz, 
      Spain.
FAU - Del Pino Algarrada, Rogelio
AU  - Del Pino Algarrada R
AD  - Unidad de Gestion Clinica de Rehabilitacion, Hospital Puerto Real, Puerto Real, 
      Cadiz, Spain.
AD  - Grupo iRehab, Instituto de Investigacion e Innovacion Biomedica de Cadiz, Cadiz, 
      Spain.
LA  - eng
GR  - N/A/Merz Pharmaceuticals GmbH/
PT  - Journal Article
DEP - 20200408
PL  - England
TA  - BMC Neurol
JT  - BMC neurology
JID - 100968555
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
RN  - EC 3.4.24.69 (incobotulinumtoxinA)
SB  - IM
MH  - Adolescent
MH  - Botulinum Toxins, Type A/*administration & dosage
MH  - Cerebral Palsy/*drug therapy
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Infant
MH  - Male
MH  - Muscle Spasticity/*drug therapy
MH  - Muscle Weakness/chemically induced
MH  - Neuromuscular Agents/*therapeutic use
MH  - Retrospective Studies
MH  - Treatment Outcome
PMC - PMC7140581
OTO - NOTNLM
OT  - Cerebral palsy
OT  - Pediatric rehabilitation
OT  - Spasticity
COIS- The authors declare no competing interests.
EDAT- 2020/04/10 06:00
MHDA- 2020/09/08 06:00
PMCR- 2020/04/08
CRDT- 2020/04/10 06:00
PHST- 2019/09/12 00:00 [received]
PHST- 2020/03/26 00:00 [accepted]
PHST- 2020/04/10 06:00 [entrez]
PHST- 2020/04/10 06:00 [pubmed]
PHST- 2020/09/08 06:00 [medline]
PHST- 2020/04/08 00:00 [pmc-release]
AID - 10.1186/s12883-020-01702-7 [pii]
AID - 1702 [pii]
AID - 10.1186/s12883-020-01702-7 [doi]
PST - epublish
SO  - BMC Neurol. 2020 Apr 8;20(1):126. doi: 10.1186/s12883-020-01702-7.