Evidence map›Paper›PMID 34957954›Full record

Trial reportNeuroRehabilitation2022

Efficacy and safety of onabotulinumtoxinA with standardized physiotherapy for the treatment of pediatric lower limb spasticity: A randomized, placebo-controlled, phase III clinical trial.

Rozalina Dimitrova, Heakyung Kim, Jill Meilahn, Henry G Chambers, Brad A Racette, Marcin Bonikowski, Eun Sook Park, Emily McCusker, Chengcheng Liu, Mitchell F Brin

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

Trial report in NeuroRehabilitation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01603628 (BOTOX® Treatment in Pediatric Lower Limb Spasticity), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 12% 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.

NCT01603628 phase3completednot on this map

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

TypeinterventionalSponsorAllerganRan2012 to 2017Enrolled384ConditionsPediatrics, Muscle Spasticity, Cerebral PalsyArmsbotulinum toxin Type A, Normal Saline (Placebo)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
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  10. Article
  11. Review
  12. The state of the art in therapeutic administration of botulinum toxin in children with cerebral palsy: an integrative review.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2024
    Review
  13. Article
  14. 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

10 authors at 7 institutions in 3 countries.

Rozalina DimitrovaAllergan, an AbbVie company, Irvine, CA, USA.
Heakyung KimColumbia University Medical Center, New York, NY, USA.
Jill MeilahnMarshfield Clinic Health System, Marshfield, WI, USA.
Henry G ChambersRady Children's Hospital, San Diego, CA, USA.
Brad A RacetteWashington University School of Medicine, St. Louis, MO, USA.
Marcin BonikowskiMazovian Neuropsychiatry Center, Zagórze, Poland.
Eun Sook ParkYonsei University College of Medicine, Seoul, Korea.
Emily McCuskerAllergan, an AbbVie company, Irvine, CA, USA.
Chengcheng LiuAllergan, an AbbVie company, Madison, NJ, USA.
Mitchell F BrinAllergan, an AbbVie company, Irvine, CA, USA.
AbbVie (United States) · USColumbia University Irving Medical Center · USMarshfield Clinic · USRady Children's Hospital-San Diego · USUniversity of California, Irvine · USUniversity of the Witwatersrand · ZAYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSpasticity is common in cerebral palsy and can result in pain and diminished health-related quality of life.

objectiveTo evaluate the safety and efficacy of onabotulinumtoxinA for lower limb spasticity treatment in children with cerebral palsy.

methodsIn this registrational phase 3, multinational, randomized, double-blind, placebo-controlled trial (NCT01603628), children (2-< 17 years) with cerebral palsy and ankle spasticity (Modified Ashworth Scale-Bohannon [MAS] score≥2) were randomized 1 : 1 : 1 to standardized physical therapy and onabotulinumtoxinA (4 or 8 U/kg), or placebo. Primary endpoint was average change from baseline at weeks 4 and 6 in MAS ankle score. Secondary endpoints included the Modified Tardieu Scale (MTS) and Global Attainment Scale (GAS).

results381 participants were randomized. MAS scores averaged at weeks 4 and 6 were significantly reduced with both onabotulinumtoxinA doses (8 U/kg: -1.06, p = 0.010; 4 U/kg: -1.01, p = 0.033) versus placebo (-0.8). Significant improvements in average dynamic component of spasticity, measured by MTS, and in function, measured by GAS, were observed at several time points with both onabotulinumtoxinA doses versus placebo. Most adverse events were mild or moderate.

conclusionsOnabotulinumtoxinA was well tolerated and effective in reducing lower limb spasticity and improving functional outcomes versus placebo in children.

Indexed as

Botulinum Toxins, Type ANeuromuscular AgentsChildDouble-Blind MethodHumansLower ExtremityMuscle SpasticityPhysical Therapy ModalitiesQuality of LifeTreatment OutcomeBotulinum Toxins, Type ANeuromuscular AgentsChildrenlower limbonabotulinumtoxinArandomized clinical trialspasticity

Identifiers

PMID34957954
PMCPMC8925123
OpenAlexW4200222599

What OpenQuestion holds

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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.