Evidence map›Paper›PMID 33419261›Full record

Trial reportToxins2020

Tolerability and Efficacy of Customized IncobotulinumtoxinA Injections for Essential Tremor: A Randomized, Double-Blind, Placebo-Controlled Study.

Mandar Jog, Jack Lee, Astrid Scheschonka, Robert Chen, Farooq Ismail, Chris Boulias, Douglas Hobson, David King, Michael Althaus, Olivier Simon and 3 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Toxins, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02207946 (Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of NT 201 in the Unilateral Treatment of Essential Tremor of the Upper Limb), which is not on this map. Cited by 21 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 6 pooled it
0.7field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02207946 phase2completednot on this map

Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of NT 201 in the Unilateral Treatment of Essential Tremor of the Upper Limb

TypeinterventionalSponsorMerz Pharmaceuticals GmbHRan2014 to 2016Enrolled30ConditionsEssential Tremor of the Upper LimbsArmsIncobotulinumtoxinA, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 6 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Diagnosis and Treatment of Essential Tremor.Continuum (Minneapolis, Minn.) · 2022
    Review
  19. Essential tremor: Clinical perspectives and pathophysiology.Journal of the neurological sciences · 2022
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 3 countries.

Mandar JogLawson Health Research Institute, London, ON N6C2R5, Canada.ORCID 0000-0001-7513-8651
Jack LeeLawson Health Research Institute, London, ON N6C2R5, Canada.
Astrid ScheschonkaMerz Pharmaceuticals GmbH, 60318 Frankfurt am Main, Germany.ORCID 0000-0003-4745-0853
Robert ChenKrembil Brain Institute, University Health Network, University of Toronto, Toronto, ON M5T1M8, Canada.ORCID 0000-0002-8371-8629
Farooq IsmailWest Park Healthcare Center, University of Toronto, Toronto, ON M6M2J5, Canada.
Chris BouliasWest Park Healthcare Center, University of Toronto, Toronto, ON M6M2J5, Canada.
Douglas HobsonDepartment of Neurology, University of Manitoba, Winnipeg, MB R3T2N2, Canada.
David KingDivision of Neurology, Dalhousie University, Halifax, NS B3H4R2, Canada.
Michael AlthausMerz Pharmaceuticals GmbH, 60318 Frankfurt am Main, Germany.
Olivier SimonMerz Pharmaceuticals GmbH, 60318 Frankfurt am Main, Germany.
Hanna DerschMerz Pharmaceuticals GmbH, 60318 Frankfurt am Main, Germany.
Steven FruchtDivision of Movement Disorders, New York University Langone Medical Center, New York, NY 10016, USA.
David M SimpsonDepartment of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
MerLion Pharma (Germany) · DELawson Health Research Institute · CAUniversity of Toronto · CADalhousie University · CAIcahn School of Medicine at Mount Sinai · USNYU Langone Health · USUniversity Health Network · CAUniversity of Manitoba · CA

Funding

Merz Pharmaceuticals n/a
6 · The paper itself

Abstract

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,

Indexed as

AdultAgedAged, 80 and overBotulinum Toxins, Type ADouble-Blind MethodEssential TremorFemaleFollow-Up StudiesHumansInjections, IntramuscularMaleMiddle AgedNeuromuscular AgentsProspective StudiesPsychomotor PerformanceTreatment OutcomeBotulinum Toxins, Type AincobotulinumtoxinANeuromuscular Agentsbotulinum toxinclinical-decision supportincobotulinumtoxinAkinematicstreatment planningtremorTremorTek®upper-limb essential tremorXeomin

Identifiers

PMID33419261
PMCPMC7766785
OpenAlexW3117078967

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.