Evidence map›Paper›PMID 34334431›Full record

Trial reportNeuroRehabilitation2021

Efficacy and safety of onabotulinumtoxinA with standardized occupational therapy for treatment of pediatric upper limb spasticity: Phase III placebo-controlled randomized trial.

Rozalina Dimitrova, Emily McCusker, Mark Gormley, Darcy Fehlings, Katharine E Alter, Susan Greaves, Chengcheng Liu, Mitchell F Brin

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in NeuroRehabilitation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01603602 (BOTOX® Treatment in Pediatric Upper Limb Spasticity), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
2.1field-weighted citation impact, top 11% 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.

NCT01603602 phase3completednot on this map

BOTOX® Treatment in Pediatric Upper Limb Spasticity: Double-blind Study

TypeinterventionalSponsorAllerganRan2012 to 2017Enrolled235ConditionsPediatrics, Muscle Spasticity, Cerebral Palsy, StrokeArmsbotulinum toxin Type A, Normal Saline (Placebo)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
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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 6 institutions in 3 countries.

Rozalina DimitrovaAllergan, an AbbVie company, Irvine, CA, USA.
Emily McCuskerAllergan, an AbbVie company, Irvine, CA, USA.
Mark GormleyGillette Children's Specialty Healthcare, St Paul, MN, USA.
Darcy FehlingsHolland Bloorview Kids Rehab Hospital, Department of Paediatrics, Toronto, ON, Canada.
Katharine E AlterMount Washington Pediatric Hospital, Baltimore, MD, USA.
Susan GreavesThe Royal Children's Hospital, Melbourne, Victoria, Australia.
Chengcheng LiuAllergan, an AbbVie company, Madison, NJ, USA.
Mitchell F BrinAllergan, an AbbVie company, Irvine, CA, USA.
AbbVie (United States) · USGillette Children's Specialty Healthcare · USHolland Bloorview Kids Rehabilitation Hospital · CAMt. Washington Pediatric Hospital · USRoyal Children's Hospital · AUUniversity of California, Irvine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis is the first large study of onabotulinumtoxinA as treatment for pediatric upper limb spasticity.

objectiveEvaluate efficacy and safety of a single treatment with onabotulinumtoxinA plus occupational therapy (OT).

methodsIn this registrational phase III, multinational study (NCT01603602), participants were randomized 1:1:1 to onabotulinumtoxinA 3 U/kg/OT, 6 U/kg/OT, or placebo/OT. Primary endpoint was average change from baseline at weeks 4 and 6 in Modified Ashworth Scale-Bohannon (MAS) score. Secondary endpoints included Modified Tardieu Scale (MTS), Clinical Global Impression of Change (CGI) and functional Goal Attainment Scale (GAS).

results235 participants were randomized. At weeks 4 and 6, onabotulinumtoxinA groups had greater mean reductions in MAS (both -1.9; p < 0.001) versus placebo (-1.2). OnabotulinumtoxinA doses improved dynamic tone per MTS. Mean CGI at weeks 4 and 6 was unchanged in the overall population, but improved in a post hoc analysis of patients with a single affected upper limb (UL) muscle group (elbow or wrist). GAS score for passive goals was significantly higher for 6 U/kg versus placebo at week 12. Most AEs were mild/moderate in severity; overall incidence was similar between groups.

conclusionsOnabotulinumtoxinA (3 and 6 U/kg) was safe and effective in reducing upper limb spasticity in pediatric participants.

Indexed as

Botulinum Toxins, Type ANeuromuscular AgentsOccupational TherapyAdolescentChildChild, PreschoolDouble-Blind MethodHumansMuscle SpasticityTreatment OutcomeUpper ExtremityBotulinum Toxins, Type ANeuromuscular AgentsChildrenonabotulinumtoxinArandomized clinical trialspasticityupper limb

Identifiers

PMID34334431
PMCPMC8673521
OpenAlexW3188081715

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.