Evidence map›Paper›PMID 23876024›Full record

Trial reportEpilepsia2013

Results of phase II levetiracetam trial following acute head injury in children at risk for posttraumatic epilepsy.

Phillip L Pearl, Robert McCarter, Colleen L McGavin, Yuezhou Yu, Fabian Sandoval, Stacey Trzcinski, Shireen M Atabaki, Tammy Tsuchida, John van den Anker, Jianping He and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Epilepsia, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01463033 (Pilot), which is not on this map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
5.7field-weighted citation impact, top 4% 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.

NCT01463033 phase2completednot on this map

Pilot: Levetiracetam to Prevent Post-Traumatic Epilepsy

TypeinterventionalSponsorPavel KleinRan2005 to 2010Enrolled126ConditionsEpilepsy, Post-traumatic EpilepsyArmsLevetiracetam
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Regulation of Inflammation-Related Genes throughInternational journal of molecular sciences · 2022
    Article
  10. Article
  11. Early Post-traumatic Seizure Occurrence in Pediatric Patients Receiving Levetiracetam Prophylaxis With Severe Traumatic Brain Injury.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2020
    Article
  12. Effect of epileptiform abnormality burden on neurologic outcome and antiepileptic drug management after subarachnoid hemorrhage.Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2018
    Article
  13. Predictors of post-discharge seizures in children with traumatic brain injury.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2018
    Article
  14. Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Pediatric head injury: a pain for the emergency physician?Clinical and experimental emergency medicine · 2015
    Review
  20. The potential of antiseizure drugs and agents that act on novel molecular targets as antiepileptogenic treatments.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2014
    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

11 authors at 2 institutions in 1 country.

Phillip L PearlDepartment of Neurology, Children's National Medical Center, Washington, District of Columbia, USA.
Robert McCarter
Colleen L McGavin
Yuezhou Yu
Fabian Sandoval
Stacey Trzcinski
Shireen M Atabaki
Tammy Tsuchida
John van den Anker
Jianping He
Pavel Klein
Children's National · USMid Atlantic Epilepsy and Sleep Center · US

Funding

Pilot: Levetiracetam to Prevent Post-Traumatic EpilepsyR01NS045656 · NINDS · MEDSTAR RESEARCH INSTITUTE · PI KLEIN, PAVEL · 2004 to 2006
$1.8M
NINDS NIH HHS 1 R01 NS45656NINDS NIH HHS R01 NS045656
6 · The paper itself

Abstract

Posttraumatic seizures develop in up to 20% of children following severe traumatic brain injury (TBI). Children ages 6-17 years with one or more risk factors for the development of posttraumatic epilepsy, including presence of intracranial hemorrhage, depressed skull fracture, penetrating injury, or occurrence of posttraumatic seizure were recruited into this phase II study. Treatment subjects received levetiracetam 55 mg/kg/day, b.i.d., for 30 days, starting within 8 h postinjury. The recruitment goal was 20 treated patients. Twenty patients who presented within 8-24 h post-TBI and otherwise met eligibility criteria were recruited for observation. Follow-up was for 2 years. Forty-five patients screened within 8 h of head injury met eligibility criteria and 20 were recruited into the treatment arm. The most common risk factor present for pediatric inclusion following TBI was an immediate seizure. Medication compliance was 95%. No patients died; 19 of 20 treatment patients were retained and one observation patient was lost to follow-up. The most common severe adverse events in treatment subjects were headache, fatigue, drowsiness, and irritability. There was no higher incidence of infection, mood changes, or behavior problems among treatment subjects compared to observation subjects. Only 1 (2.5%) of 40 subjects developed posttraumatic epilepsy (defined as seizures >7 days after trauma). This study demonstrates the feasibility of a pediatric posttraumatic epilepsy prevention study in an at-risk traumatic brain injury population. Levetiracetam was safe and well tolerated in this population. This study sets the stage for implementation of a prospective study to prevent posttraumatic epilepsy in an at-risk population.

Indexed as

AdolescentAnticonvulsantsBrain InjuriesChildCraniocerebral TraumaEpilepsy, Post-TraumaticFemaleHumansIrritable MoodLevetiracetamMalePiracetamProspective StudiesRisk FactorsTreatment OutcomeAnticonvulsantsLevetiracetamPiracetamLevetiracetamPediatricPosttraumatic epilepsy

Identifiers

PMID23876024
PMCPMC3769484
OpenAlexW2030267707

What OpenQuestion holds

Textmetadata
LicenceTDM
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.