Evidence map›Paper›PMID 39716821›Full record

ArticleJournal of child neurology2025

Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Pediatric Upper and Lower Limb Spasticity: Results From 2 Open-Label, Long-term Extension Trials.

Mark Gormley, Darcy Fehlings, Heakyung Kim, Marcin Bonikowski, Marta Banach, Fatma Gul, Jill Meilahn, Brad Racette, Nuoyu Huang, Xiaomeng Niu and 2 more

Abstract read
In one paragraph

Article in Journal of child neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
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

12 authors.

Mark GormleyDepartment of Physical Medicine and Rehabilitation, Gillette Children's Specialty Healthcare, St. Paul, MN, USA.
Darcy FehlingsHolland Bloorview Kids Rehabilitation Hospital/Department of Paediatrics, University of Toronto, Toronto, ON, Canada.
Heakyung KimDepartment of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Marcin BonikowskiDepartment of Neurorehabilitation, MCN Zagórze, Zagórze, Poland.
Marta BanachDepartment of Neurology, Jagiellonian University, Krakow, Poland.
Fatma GulDepartment of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Jill MeilahnDepartment of Physical Medicine and Rehabilitation, Marshfield Clinic Health System, Marshfield, WI, USA.
Brad RacetteDepartment of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.
Nuoyu HuangDepartment of Pharmacovigilance and Patient Safety, Allergan, an AbbVie Company, Madison, NJ, USA.
Xiaomeng NiuDepartment of Biostatistics, Allergan, an AbbVie Company, Madison, NJ, USA.
Lynn M JamesDepartment of Global Development, Allergan, an AbbVie Company, Irvine, CA, USA.ORCID 0000-0003-2527-2187
Rozalina DimitrovaDepartment of Global Development, Allergan, an AbbVie Company, Irvine, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

AimTo evaluate the efficacy and safety of onabotulinumtoxinA for treating upper and lower limb spasticity among pediatric patients in 2 open-label extension trials.MethodsPatients aged <18 years received ≤5 doses of onabotulinumtoxinA (maximum: 8 U/kg [300 U], cycle 1; 10 U/kg [340 U], cycles 2-5) over 60 weeks. Week 6 efficacy endpoints included mean change from baseline in Modified Ashworth Scale-Bohannon and Modified Tardieu Scale scores, and mean Clinical Global Impression of Overall Change score. Adverse events and laboratory assessments of bone health were monitored.ResultsA total of 580 patients received onabotulinumtoxinA. Modified Ashworth Scale-Bohannon change from baseline ranged from -1.01 to -1.9. Modified Tardieu Scale change from baseline was 13.6 to 18.1 (ankle), 25.8 to 44.1 (elbow), and -5.0 to -26.3 (wrist). Clinical Global Impression of Overall Change scores were 1.5 to 2.2. The most common treatment-emergent adverse events were upper respiratory tract infection (16.9%) and nasopharyngitis (15.7%).InterpretationRepeat administration of onabotulinumtoxinA was safe and efficacious for treating upper and lower limb spasticity in children.

Indexed as

Botulinum Toxins, Type ALower ExtremityMuscle SpasticityNeuromuscular AgentsUpper ExtremityAdolescentCerebral PalsyChildChild, PreschoolFemaleHumansMaleTreatment OutcomeBotulinum Toxins, Type ANeuromuscular Agentsonabotulinum toxin Acerebral palsychildrenoutcomepediatricspasticitystroketreatment

Identifiers

PMID39716821
PMCPMC11909783

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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.