PMID- 34339951
OWN - NLM
STAT- MEDLINE
DCOM- 20220221
LR  - 20220221
IS  - 1873-5150 (Electronic)
IS  - 0887-8994 (Linking)
VI  - 123
DP  - 2021 Oct
TI  - IncobotulinumtoxinA Efficacy/Safety in Upper-Limb Spasticity in Pediatric 
      Cerebral Palsy: Randomized Controlled Trial.
PG  - 10-20
LID - S0887-8994(21)00108-9 [pii]
LID - 10.1016/j.pediatrneurol.2021.05.014 [doi]
AB  - BACKGROUND: This randomized phase 3 study with double-blind main period (MP) and 
      open-label extension (OLEX; NCT02002884) assessed incobotulinumtoxinA safety and 
      efficacy for pediatric upper-limb spasticity treatment in ambulant/nonambulant 
      (Gross Motor Function Classification System [GMFCS] I-V) patients, with the 
      option of combined upper- and lower-limb treatment. METHODS: Patients were aged 
      two to 17 years with unilateral or bilateral spastic cerebral palsy (CP) and 
      Ashworth Scale (AS) score >/=2 in treatment-selected clinical patterns. In the MP, 
      patients were randomized (2:1:1) to incobotulinumtoxinA 8, 6, or 2 U/kg body 
      weight (maximum 200, 150, 50 U/upper limb), with optional lower-limb injections 
      in one of five topographical distributions (total body dose </=16 to 20 U/kg, 
      maximum 400 to 500 U, depending on body weight and GMFCS level). In the OLEX, 
      patients received three further treatment cycles, at the highest MP doses (8 
      U/kg/upper limb group). Outcomes included AS, Global Impression of Change Scale 
      (GICS), and adverse events (AEs). RESULTS: AS scores improved from baseline to 
      week 4 in all MP dose groups (n = 350); patients in the incobotulinumtoxinA 8 
      U/kg group had significantly greater spasticity improvements versus the 2 U/kg 
      group (least-squares mean [standard error] for upper-limb main clinical target 
      pattern -1.15 [0.06] versus -0.93 [0.08]; P = 0.017). Investigator's, 
      child/adolescent's, and parent/caregiver's GICS scores showed improvements in all 
      groups. Treatment benefits were sustained over further treatment cycles. AE 
      incidence did not increase with dose or repeated treatment across GMFCS levels. 
      CONCLUSIONS: Data provide evidence for sustained efficacy and safety of 
      multipattern incobotulinumtoxinA treatment in children and adolescents with 
      upper-limb spasticity.
CI  - Copyright (c) 2021 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Dabrowski, Edward
AU  - Dabrowski E
AD  - Beaumont Pediatric Physical Medicine & Rehabilitation - Royal Oak, Royal Oak, 
      Michigan. Electronic address: Edward.Dabrowski@beaumont.edu.
FAU - Chambers, Henry G
AU  - Chambers HG
AD  - Rady Children's Hospital, San Diego, California.
FAU - Gaebler-Spira, Deborah
AU  - Gaebler-Spira D
AD  - Shirley Ryan AbilityLab Northwestern Feinberg School of Medicine, Chicago, 
      Illinois.
FAU - Banach, Marta
AU  - Banach M
AD  - Department of Neurology, Collegium Medicum, Jagiellonian University, Krakow, 
      Poland.
FAU - Kanovsky, Petr
AU  - Kanovsky P
AD  - Faculty of Medicine and Dentistry and University Hospital, Palacky University 
      Olomouc, Olomouc, Czech Republic.
FAU - Dersch, Hanna
AU  - Dersch H
AD  - Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.
FAU - Althaus, Michael
AU  - Althaus M
AD  - Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.
FAU - Geister, Thorin L
AU  - Geister TL
AD  - Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.
FAU - Heinen, Florian
AU  - Heinen F
AD  - LMU Klinikum Munich, Division of Pediatric Neurology & LMU Center for Children 
      with Medical Complexity, Dr. von Hauner Children's Hospital, 
      Ludwig-Maximilians-University, Munich, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02002884
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210521
PL  - United States
TA  - Pediatr Neurol
JT  - Pediatric neurology
JID - 8508183
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/adverse effects/*pharmacology
MH  - Cerebral Palsy/complications/*drug therapy
MH  - Child
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Muscle Spasticity/*drug therapy/etiology/*physiopathology
MH  - Neuromuscular Agents/administration & dosage/adverse effects/*pharmacology
MH  - Outcome Assessment, Health Care
MH  - Upper Extremity/*physiopathology
OTO - NOTNLM
OT  - Botulinum neurotoxin A
OT  - Cerebral palsy
OT  - IncobotulinumtoxinA
OT  - Multipattern treatment
OT  - Pediatric
OT  - Spasticity
EDAT- 2021/08/03 06:00
MHDA- 2022/02/22 06:00
CRDT- 2021/08/02 20:19
PHST- 2021/01/19 00:00 [received]
PHST- 2021/05/07 00:00 [revised]
PHST- 2021/05/15 00:00 [accepted]
PHST- 2021/08/03 06:00 [pubmed]
PHST- 2022/02/22 06:00 [medline]
PHST- 2021/08/02 20:19 [entrez]
AID - S0887-8994(21)00108-9 [pii]
AID - 10.1016/j.pediatrneurol.2021.05.014 [doi]
PST - ppublish
SO  - Pediatr Neurol. 2021 Oct;123:10-20. doi: 10.1016/j.pediatrneurol.2021.05.014. 
      Epub 2021 May 21.