Evidence map›Paper›PMID 22771222›Full record

Trial reportEpilepsy & behavior : E&B2012

Results of phase II pharmacokinetic study of levetiracetam for prevention of post-traumatic epilepsy.

Pavel Klein, Daniel Herr, Phillip L Pearl, JoAnne Natale, Zachary Levine, Claude Nogay, Fabian Sandoval, Stacey Trzcinsky, Shireen M Atabaki, Tammy Tsuchida and 4 more

2 registry-linked trialsAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Epilepsy & behavior : E&B, 2012. 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 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.5field-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.

NCT01463033 phase2completednot on this map

Pilot: Levetiracetam to Prevent Post-Traumatic Epilepsy

TypeinterventionalSponsorPavel KleinRan2005 to 2010Enrolled126ConditionsEpilepsy, Post-traumatic EpilepsyArmsLevetiracetam
NCT04836481 completednot on this mapstarted 2021, after this paper: background citation

A Pharmacokinetic Analysis of Levetiracetam Prophylaxis in Critically Ill Patients With Severe Traumatic Brain Injury

TypeobservationalSponsorUniversity of CincinnatiRan2021 to 2023Enrolled10ConditionsTraumatic Brain InjuryArmsSerum Sample Collection
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Levetiracetam Pharmacokinetics and Brain Uptake in a Lateral Fluid Percussion Injury Rat Model.The Journal of pharmacology and experimental therapeutics · 2023
    Article
  5. Article
  6. Feasibility of Using Oral Fluid for Therapeutic Drug Monitoring of Antiepileptic Drugs.European journal of drug metabolism and pharmacokinetics · 2021
    Review
  7. Review
  8. Article
  9. Review
  10. Epilepsy related to traumatic brain injury.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2014
    Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Pharmacological Intervention of Post-traumatic Seizure: Advanced Research Progress.Dose-response : a publication of International Hormesis Society
    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

14 authors at 3 institutions in 1 country.

Pavel KleinDepartment of Neurology, MedStar Research Institute, Washington, D.C. 20010, USA. kleinp@epilepsydc.com
Daniel Herr
Phillip L Pearl
JoAnne Natale
Zachary Levine
Claude Nogay
Fabian Sandoval
Stacey Trzcinsky
Shireen M Atabaki
Tammy Tsuchida
John van den Anker
Steven J Soldin
Jianping He
Robert McCarter
Children's National · USMedStar Health · USMid Atlantic Epilepsy and Sleep Center · US

Funding

Georgetown-Howard Universities Center for Clinical and Translational Science (GHUUL1TR000101 · NCATS · GEORGETOWN UNIVERSITY · PI MELLMAN, THOMAS A, VERBALIS, JOSEPH G · 2012 to 2015
$19.3M
NEUROIMAGING COREP30HD040677 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI MCCARTER, ROBERT JAMES · 2001 to 2015
$15.9M
ZAP-70 EXPRESSION, CD38 EXPRESSION AND PROGNOSIS IN CHRONIC LYMPHOCYTIC LEUKEMIAM01RR020359 · NCRR · CHILDREN'S RESEARCH INSTITUTE · PI MIRZA, NAZRAT · 2005 to 2010
$13.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR031988 · NCRR · CHILDREN'S RESEARCH INSTITUTE · PI JOSEPH, JILL G · 2010 to 2011
$8.2M
Pilot: Levetiracetam to Prevent Post-Traumatic EpilepsyR01NS045656 · NINDS · MEDSTAR RESEARCH INSTITUTE · PI KLEIN, PAVEL · 2004 to 2006
$1.8M
Clinical and Translational Science Institute at Children's NationalKL2RR031987 · NCRR · CHILDREN'S RESEARCH INSTITUTE · PI GUAY-WOODFORD, LISA MARIE · 2010 to 2011
$425k
Role of Mass Spectrometry in Improving the Diagnosis of Endocrine DisordersZIACL010355 · CLC · CLINICAL CENTER · PI SOLDIN, STEVEN · 2014 to 2020
$0k
NCATS NIH HHS UL1 TR000101NCRR NIH HHS KL2 RR031987NCRR NIH HHS M01 RR020359NCRR NIH HHS M01RR020359NCRR NIH HHS UL1 RR031988NCRR NIH HHS UL1RR031988NICHD NIH HHS P30 HD040677NICHD NIH HHS P30HD040677NINDS NIH HHS 1 R01 NS45656NINDS NIH HHS R01 NS045656
6 · The paper itself

Abstract

Levetiracetam (LEV) has antiepileptogenic effects in animals and is a candidate for prevention of epilepsy after traumatic brain injury. Pharmacokinetics of LEV in TBI patients was unknown. We report pharmacokinetics of TBI subjects≥6years with high PTE risk treated with LEV 55mg/kg/day orally, nasogastrically or intravenously for 30days starting ≤8h after injury in a phase II safety and pharmacokinetic study. Forty-one subjects (26 adults and 15 children) were randomized to PK studies on treatment days 3 and 30. Thirty-six out of forty-one randomized subjects underwent PK study on treatment day 3, and 24/41 subjects underwent PK study on day 30. On day 3, mean T(max) was 2.2h, C(max) was 60.2μg/ml and AUC was 403.7μg/h/ml. T(max) was longer in the elderly than in children and non-elderly adults (5.96h vs. 1.5h and 1.8h; p=0.0001). AUC was non-significantly lower in children compared with adults and the elderly (317.4μg/h/ml vs. 461.4μg/h/ml and 450.2μg/h/ml; p=0.08). C(max) trended higher in i.v.- versus tablet- or n.g.-treated subjects (78.4μg/ml vs. 59μg/ml and 48.2μg/ml; p=0.07). AUC of n.g. and i.v. administrations was 79% and 88% of AUC of oral administration. There were no significant PK differences between days 3 and 30. Treatment of TBI patients with high PTE risk with 55mg/kg/day LEV, a dose with antiepileptogenic effect in animals, results in plasma LEV levels comparable to those in animal studies.

Indexed as

AdolescentAdultAgedAged, 80 and overAge FactorsAnalysis of VarianceAnticonvulsantsArea Under CurveBrain InjuriesChildCreatinineEpilepsyFemaleFollow-Up StudiesGlasgow Coma ScaleHumansAnticonvulsantsCreatinineLevetiracetamPiracetamProtein Kinases

Identifiers

PMID22771222
PMCPMC4561854
OpenAlexW2073215785

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.