Tolerability and Efficacy of Customized IncobotulinumtoxinA Injections for Essential Tremor: A Randomized, Double-Blind, Placebo-Controlled Study.
Adult
Aged
Aged, 80 and over
Botulinum Toxins, Type A
/ administration & dosage
Double-Blind Method
Essential Tremor
/ diagnosis
Female
Follow-Up Studies
Humans
Injections, Intramuscular
Male
Middle Aged
Neuromuscular Agents
/ administration & dosage
Prospective Studies
Psychomotor Performance
/ drug effects
Treatment Outcome
TremorTek®
Xeomin
botulinum toxin
clinical-decision support
incobotulinumtoxinA
kinematics
treatment planning
tremor
upper-limb essential tremor
Journal
Toxins
ISSN: 2072-6651
Titre abrégé: Toxins (Basel)
Pays: Switzerland
ID NLM: 101530765
Informations de publication
Date de publication:
20 Dec 2020
20 Dec 2020
Historique:
received:
04
12
2020
accepted:
14
12
2020
entrez:
9
1
2021
pubmed:
10
1
2021
medline:
24
6
2021
Statut:
epublish
Résumé
In this first, double-blind, randomized, placebo-controlled exploratory trial, we evaluate the efficacy and safety of incobotulinumtoxinA and feasibility of using kinematic tremor assessment to aid in the planning of muscle selection in a multicenter setting. Reproducibility of the planning technology to other clinical sites was explored. In this trial (NCT02207946), patients with upper-limb essential tremor (ET) were randomized 2:1 to a single treatment cycle of incobotulinumtoxinA or placebo. A tremor kinematic analytics investigational device was used to define a customized muscle set for injection, related to the pattern of the wrist, forearm, elbow, and shoulder tremor for each patient, and the incobotulinumtoxinA dose per muscle (total ≤ 200 U). Fahn-Tolosa-Marin (FTM) Part B motor performance score, Global Impression of Change Scale (GICS), and kinematic analysis-based efficacy evaluations were assessed. Thirty patients were randomized (incobotulinumtoxinA,
Identifiants
pubmed: 33419261
pii: toxins12120807
doi: 10.3390/toxins12120807
pmc: PMC7766785
pii:
doi:
Substances chimiques
Neuromuscular Agents
0
Botulinum Toxins, Type A
EC 3.4.24.69
incobotulinumtoxinA
EC 3.4.24.69
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Merz Pharmaceuticals
ID : n/a
Pays : International
Références
Neurology. 2008 May 6;70(19):1699-706
pubmed: 18458230
Eur J Neurol. 2013 Jun;20(6):949-54
pubmed: 23521518
Cerebellum. 2014 Aug;13(4):501-12
pubmed: 24435423
Neurology. 2011 Nov 8;77(19):1752-5
pubmed: 22013182
J Child Neurol. 2011 Jul;26(7):822-9
pubmed: 21421904
Mov Disord Clin Pract. 2019 Sep 09;6(8):652-655
pubmed: 31745472
Mov Disord. 2018 Jan;33(1):75-87
pubmed: 29193359
Clin Biomech (Bristol, Avon). 2011 Oct;26(8):811-8
pubmed: 21555172
Tremor Other Hyperkinet Mov (N Y). 2015 Oct 30;5:348
pubmed: 26566459
Neurology. 2001 Jun 12;56(11):1523-8
pubmed: 11402109
J Cent Nerv Syst Dis. 2014 Apr 21;6:29-39
pubmed: 24812533
Tremor Other Hyperkinet Mov (N Y). 2019 Jul 26;9:
pubmed: 31413896
Neurology. 1989 Dec;39(12):1587-8
pubmed: 2586774
Can J Neurol Sci. 2013 Sep;40(5):663-9
pubmed: 23968939
Parkinsonism Relat Disord. 2018 Nov;56:65-69
pubmed: 29929813
Toxins (Basel). 2019 Feb 19;11(2):
pubmed: 30791440
Mov Disord. 1996 May;11(3):250-6
pubmed: 8723140
J Cent Nerv Syst Dis. 2013 Dec 22;5:43-55
pubmed: 24385718
PLoS One. 2016 Apr 21;11(4):e0153739
pubmed: 27101283
Mov Disord. 2010 Apr 15;25(5):534-41
pubmed: 20175185
PLoS One. 2017 Jun 6;12(6):e0178670
pubmed: 28586370
Mov Disord. 1998;13 Suppl 3:2-23
pubmed: 9827589