Evidence map›Paper›PMID 24311644›Full record

Trial reportNeuro-oncology2014

Levetiracetam and pregabalin for antiepileptic monotherapy in patients with primary brain tumors. A phase II randomized study.

Andrea O Rossetti, Sandrine Jeckelmann, Jan Novy, Patrick Roth, Michael Weller, Roger Stupp

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

Trial report in Neuro-oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00629889 (Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.), which is not on this map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 pooled it
4.0field-weighted citation impact, top 6% 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.

NCT00629889 phase2completednot on this map

Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.

TypeinterventionalSponsorDr Andrea RossettiRan2008 to 2013Enrolled52ConditionsBrain and Central Nervous System Tumors, SeizureArmslevetiracetam, pregabalin
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Management of epilepsy in brain tumors.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2019
    Guideline
  3. Pooled it
  4. Pooled it
  5. Review
  6. Review
  7. Article
  8. Observational
  9. Review
  10. Patient-Centered Management of Brain Tumor-Related Epilepsy.Current neurology and neuroscience reports · 2024
    Review
  11. Review
  12. Review
  13. Observational
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Clinical Trial Design for Disease-Modifying Therapies for Genetic Epilepsies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021
    Review
  20. 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

6 authors at 2 institutions in 1 country.

Andrea O RossettiDepartment of Clinical Neurosciences, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland (A.O.R., J.N., R.S.); Multidisciplinary Oncology Center, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland (S.J.); Department of Neurology, Universitätspital Zürich, Zurich, Switzerland (P.R., M.W.).
Sandrine Jeckelmann
Jan Novy
Patrick Roth
Michael Weller
Roger Stupp
University of Lausanne · CHUniversity Hospital of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with brain tumors, the choice of antiepileptic medication is guided by tolerability and pharmacokinetic interactions. This study investigated the effectiveness of levetiracetam (LEV) and pregabalin (PGB), 2 non-enzyme-inducing agents, in this setting.

methodsIn this pragmatic, randomized, unblinded phase II trial (NCT00629889), patients with primary brain tumors and epilepsy were titrated to a monotherapy of LEV or PGB. Efficacy and tolerability were assessed using structured questionnaires. The primary composite endpoint was the need to discontinue the study drug, add-on of a further antiepileptic treatment, or occurrence of at least 2 seizures with impaired consciousness during 1 year follow-up.

resultsOver 40 months, 25 patients were randomized to LEV, and 27 to PGB. Most were middle-aged men, with a high-grade tumor and at least one generalized convulsion. Mean daily doses were 1125 mg (LEV) and 294 mg (PGB). Retention rates were 59% in the LEV group, and 41% in the PGB group. The composite endpoint was reached in 9 LEV and 12 PGB patients-need to discontinue: side effects, 6 LEV, 3 PGB; lack of efficacy, 1 and 2; impaired oral administration, 0 and 2; add-on of another agent: 1 LEV, 4 PGB; and seizures impairing consciousness: 1 in each. Seven LEV and 5 PGB subjects died of tumor progression.

conclusionsThis study shows that LEV and PGB represent valuable monotherapy options in this setting, with very good antiepileptic efficacy and an acceptable tolerability profile, and provides important data for the design of a phase III trial.

Indexed as

AnticonvulsantsBrain NeoplasmsEpilepsyFemaleFollow-Up Studiesgamma-Aminobutyric AcidHumansLevetiracetamMaleMiddle AgedNeoplasm GradingNeoplasm Recurrence, LocalPiracetamPregabalinPrognosisSurvival RateAnticonvulsantsgamma-Aminobutyric AcidLevetiracetamPiracetamPregabalinepilepsygliomaoutcomeseizuretreatment

Identifiers

PMID24311644
PMCPMC3956345
OpenAlexW2160653335

What OpenQuestion holds

Textmetadata
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.