Evidence map›Paper›PMID 33112408›Full record

Trial reportJournal of rehabilitation medicine2021

Sustained efficacy of incobotulinumtoxina repeated injections for upper-limb post-stroke spasticity: A post hoc analysis.

Petr Kaňovský, Elie P Elovic, Michael C Munin, Angelika Hanschmann, Irena Pulte, Michael Althaus, Reinhard Hiersemenzel, Christina Marciniak

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of rehabilitation medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 35% 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.

NCT00432666 phase3completednot on this map

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of incobotulinumtoxinA (Xeomin) in the Treatment of Post-stroke Spasticity of the Upper Limb

TypeinterventionalSponsorMerz Pharmaceuticals GmbHRan2006 to 2008Enrolled148ConditionsPost-stroke Upper Limb SpasticityArmsIncobotulinumtoxinA (Xeomin), Placebo
NCT01392300 phase3completednot on this map

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb

TypeinterventionalSponsorMerz Pharmaceuticals GmbHRan2011 to 2014Enrolled317ConditionsPost-stroke Spasticity of the Upper LimbArmsIncobotulinumtoxinA (400 Units), Placebo Comparator
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

8 authors at 1 institution in 1 country.

Petr KaňovskýFaculty of Medicine and Dentistry and University Hospital, Palacký University Olomouc, Olomouc, Czech Republic. E-mail: petr.kanovsky@fnol.cz.
Elie P Elovic
Michael C Munin
Angelika Hanschmann
Irena Pulte
Michael Althaus
Reinhard Hiersemenzel
Christina Marciniak
Palacký University Olomouc · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis post hoc analysis assessed the impact of repeated incobotulinumtoxinA injections on muscle tone, disability, and caregiver burden in adults with upper-limb post-stroke spasticity.

designData from the double-blind, placebo-controlled main period and three open-label extension cycles of two Phase 3, randomized, multicentre trials were pooled.

methodsSubjects received incobotulinumtoxinA 400 Units at 12-week intervals (±3 days) (study 3001, NCT01392300) or ≤ 400 Units at ≥12-week intervals based on clinical need (study 0410, NCT00432666). Ashworth Scale (AS) arm sumscore (sum of elbow, wrist, finger and thumb flexor, and forearm pronator AS scores), Disability Assessment Scale (DAS), and Carer Burden Scale (CBS) scores were assessed.

resultsAmong 465 subjects, from study baseline to 4 weeks post-injection, mean (standard deviation) AS arm sumscore improved continuously: main period, -3.23 (2.55) (placebo, -1.49 (2.09)); extension cycles 1, 2, and 3, -4.38 (2.85), -4.87 (3.05), and -5.03 (3.02), respectively. DAS principal target domain responder rate increased from 47.4% in the main period (placebo 27.2%) to 66.6% in extension cycle 3. Significant improvements in CBS scores 4 weeks post-injection accompanied improved functional disability in all cycles.

conclusionIncobotulinumtoxinA conferred sustained improvements in muscle tone, disability, and caregiver burden in subjects with upper-limb post-stroke spasticity.

Indexed as

Botulinum Toxins, Type ADouble-Blind MethodFemaleHumansMaleMiddle AgedMuscle SpasticityNeuromuscular AgentsStrokeTreatment OutcomeUpper ExtremityBotulinum Toxins, Type AincobotulinumtoxinANeuromuscular Agentsbotulinum neurotoxincaregiver burdenduration of effectincobotulinumtoxinArehabilitationspasticityupper limb

Identifiers

PMID33112408
PMCPMC8772361
OpenAlexW3097140679

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.