Evidence map›Paper›PMID 37638552›Full record

ArticleAnnals of neurology2023

Early Treatment with Vigabatrin Does Not Decrease Focal Seizures or Improve Cognition in Tuberous Sclerosis Complex: The PREVeNT Trial.

Elizabeth Martina Bebin, Jurriaan M Peters, Brenda E Porter, Tarrant O McPherson, Sarah O'Kelley, Mustafa Sahin, Katherine S Taub, Rajsekar Rajaraman, Stephanie C Randle, William M McClintock and 12 more

Registry-linked trialOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Annals of neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02849457 (Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
10.0field-weighted citation impact, top 1% 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.

NCT02849457 phase2completednot on this map

Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Randomized, Double-blind, Placebo-controlled Seizure Prevention Clinical Trial for Infants With TSC

TypeinterventionalSponsorMartina BebinRan2016 to 2023Enrolled84ConditionsTuberous Sclerosis ComplexArmsEarly Vigabatrin, Delayed Vigabatrin (Placebo)
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

  1. Pooled it
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  3. Article
  4. Neonatal Seizures in Tuberous Sclerosis Complex: A Case Series.Annals of the Child Neurology Society · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 14 institutions in 1 country.

Elizabeth Martina BebinDepartment of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.ORCID https://orcid.org/0000-0003-1264-3428
Jurriaan M PetersDepartment of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.ORCID https://orcid.org/0000-0002-6725-2814
Brenda E PorterDepartment of Neurology, Stanford University, Stanford, CA, USA.
Tarrant O McPhersonDepartment of Biostatistics and Bioinformatics, Emory University, Atlanta, GA, USA.
Sarah O'KelleyDepartment of Psychology, University of Alabama at Birmingham, Birmingham, AL, USA.
Mustafa SahinDepartment of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.ORCID https://orcid.org/0000-0001-7044-2953
Katherine S TaubDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Rajsekar RajaramanDepartment of Pediatrics and Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.
Stephanie C RandleDepartment of Pediatrics, Division Pediatric Neurology and Epilepsy, Seattle Children's Hospital, Seattle, WA, USA.
William M McClintockDepartment of Pediatrics, Division of Neurology, Children's National Medical Center, Washington, DC, USA.
Mary Kay KoenigDepartment of Pediatrics, McGovern Medical School at University of Texas Health Science Center at Houston and Children's Memorial Hermann Hospital, Houston, TX, USA.
Mike D FrostMinnesota Epilepsy Group, P.A., Minnesota Epilepsy Group, Roseville, MN, USA.
Hope A NorthrupDepartment of Pediatrics, McGovern Medical School at University of Texas Health Science Center at Houston and Children's Memorial Hermann Hospital, Houston, TX, USA.
Klaus WernerDepartment of Pediatrics, Duke University, Durham, NC, USA.
Danielle A NolanBeaumont Florence and Richard McBrien Pediatric Neuroscience Center, Beaumont Hospital, Royal Oak, MI, USA.
Michael WongDepartment of Neuroscience, Washington University in Saint Louis, Saint Louis, MO, USA.
Jessica L KreftingDepartment of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.
Fred BiasiniDepartment of Psychology, University of Alabama at Birmingham, Birmingham, AL, USA.
Kalyani PeriDepartment of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.
Gary CutterDepartment of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.
Darcy A KruegerDepartment of Pediatrics, University of Cincinnati, Cincinnati, OH, USA.ORCID https://orcid.org/0000-0002-7250-7391
PREVeNT Study Group
University of Alabama at Birmingham · USBoston Children's Hospital · USMemorial Hermann · USBeaumont Hospital, Royal Oak · USChildren's Hospital of Philadelphia · USChildren's National · USDuke University · USEmory University · USMinnesota Epilepsy Group · USSeattle Children's Hospital · USStanford University · USUniversity of California, Los Angeles · USUniversity of Cincinnati · USWashington University in St. Louis · US

Funding

Preventing Epilepsy using Vigabatrin in Infants with Tuberous Sclerosis ComplexU01NS092595 · NINDS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BEBIN, MARTINA · 2016 to 2020
$7.1M
NINDS NIH HHS NCT028494571NINDS NIH HHS U01 NS092595
6 · The paper itself

Abstract

objectiveThis study was undertaken to test the hypothesis that early vigabatrin treatment in tuberous sclerosis complex (TSC) infants improves neurocognitive outcome at 24 months of age.

methodsA phase IIb multicenter randomized double-blind placebo-controlled trial was conducted of vigabatrin at first epileptiform electroencephalogram (EEG) versus vigabatrin at seizure onset in infants with TSC. Primary outcome was Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) cognitive assessment score at 24 months. Secondary outcomes were prevalence of drug-resistant epilepsy, additional developmental outcomes, and safety of vigabatrin.

resultsOf 84 infants enrolled, 12 were screen failures, 4 went straight to open label vigabatrin, and 12 were not randomized (normal EEG throughout). Fifty-six were randomized to early vigabatrin (n = 29) or placebo (n = 27). Nineteen of 27 in the placebo arm transitioned to open label vigabatrin, with a median delay of 44 days after randomization. Bayley-III cognitive composite scores at 24 months were similar for participants randomized to vigabatrin or placebo. Additionally, no significant differences were found between groups in overall epilepsy incidence and drug-resistant epilepsy at 24 months, time to first seizure after randomization, and secondary developmental outcomes. Incidence of infantile spasms was lower and time to spasms after randomization was later in the vigabatrin group. Adverse events were similar across groups.

interpretationPreventative treatment with vigabatrin based on EEG epileptiform activity prior to seizure onset does not improve neurocognitive outcome at 24 months in TSC children, nor does it delay onset or lower the incidence of focal seizures and drug-resistant epilepsy at 24 months. Preventative vigabatrin was associated with later time to onset and lower incidence of infantile spasms. ANN NEUROL 2023.

Identifiers

PMID37638552
PMCPMC10899525
OpenAlexW4386209405

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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.