PMID- 17979859
OWN - NLM
STAT- MEDLINE
DCOM- 20071206
LR  - 20211020
IS  - 0012-1622 (Print)
IS  - 1469-8749 (Electronic)
IS  - 0012-1622 (Linking)
VI  - 49
IP  - 11
DP  - 2007 Nov
TI  - High dose botulinum toxin A for the treatment of lower extremity hypertonicity in 
      children with cerebral palsy.
PG  - 818-22
AB  - The aim of this study was to determine the safety profile of high dose (15-25 
      units/kg) of botulinum toxin A (BTX-A) in children with cerebral palsy (CP) and 
      increased lower extremity muscle tone. We performed a retrospective review of 929 
      patient encounters at the Movement Disorders Center at Washington University. A 
      total of 261 patients (105 females; 156 males) were treated during these visits, 
      ages 6 months to 21 years (mean 8 y 4 mo [SD 4 y 8 mo]). Ambulatory ability at 
      the time of BTX-A injection was independent ambulation (36.4%, n=95), ambulation 
      with a walker (27.6%, n=72), and non-ambulatory (31.8%, n=83). A few patients 
      (4.2%, n=11) were able to ambulate with a cane or crutch at the time of 
      injection. Participants were characterized according to BTX-A dose, CP etiology, 
      motor involvement pattern, muscles injected, ambulatory ability, and use of oral 
      tone medications. Follow-up records were searched for reported adverse events 
      (AEs), with a mean time to AE assessment of 6.5 weeks (SD 3.38). The AE 
      occurrence was determined for doses of 0 to 4.9 units/kg, 5 to 9.9 units/kg, 10 
      to 14.9 units/kg, 15 to 19.9 units/kg, and 20 to 25 units/kg. The overall AE 
      occurrence was 4.2%. Standard doses of BTX-A had side-effect occurrences of 3.9% 
      for 5 to 10 units/kg and 7.6% for 10 to 15 units/kg. Among higher doses (15-20 
      units/kg and 20-25 units/kg) the AE occurrence was 3.5% and 8.6% respectively. No 
      patient developed botulism. AEs were randomly distributed across dosing groups, 
      CP etiologies, clinical phenotypes, ambulatory status, and treatment duration. 
      All doses were associated with a significant increase in passive range of motion 
      using the Tardieu scale. We conclude that higher dose BTX-A is safe in children 
      with a spectrum of CP phenotypes and are well tolerated over time.
FAU - Willis, Allison W
AU  - Willis AW
AD  - Department of Neurology, Washington University School of Medicine, St Louis, MO, 
      USA.
FAU - Crowner, Beth
AU  - Crowner B
FAU - Brunstrom, Janice E
AU  - Brunstrom JE
FAU - Kissel, Abigail
AU  - Kissel A
FAU - Racette, Brad A
AU  - Racette BA
LA  - eng
GR  - T32 NS007205-23/NS/NINDS NIH HHS/United States
GR  - K23 NS043351/NS/NINDS NIH HHS/United States
GR  - R21 HD048972/HD/NICHD NIH HHS/United States
GR  - K23NS43351/NS/NINDS NIH HHS/United States
GR  - T32 NS007205/NS/NINDS NIH HHS/United States
GR  - R21HD048972/HD/NICHD NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Dev Med Child Neurol
JT  - Developmental medicine and child neurology
JID - 0006761
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Botulinum Toxins, Type A/administration & dosage/*therapeutic use
MH  - *Cerebral Palsy/drug therapy/epidemiology/physiopathology
MH  - Child
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Lower Extremity/*physiopathology
MH  - Male
MH  - *Muscle Hypertonia/drug therapy/epidemiology/physiopathology
MH  - Muscle, Skeletal/physiopathology
MH  - Neuromuscular Agents/administration & dosage/*therapeutic use
MH  - Retrospective Studies
PMC - PMC3064069
MID - NIHMS237045
EDAT- 2007/11/06 09:00
MHDA- 2007/12/07 09:00
PMCR- 2011/03/25
CRDT- 2007/11/06 09:00
PHST- 2007/11/06 09:00 [pubmed]
PHST- 2007/12/07 09:00 [medline]
PHST- 2007/11/06 09:00 [entrez]
PHST- 2011/03/25 00:00 [pmc-release]
AID - DMCN818 [pii]
AID - 10.1111/j.1469-8749.2007.00818.x [doi]
PST - ppublish
SO  - Dev Med Child Neurol. 2007 Nov;49(11):818-22. doi: 
      10.1111/j.1469-8749.2007.00818.x.