Evidence map›Paper›PMID 17283312›Full record

Trial reportNeurology2007

Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy.

M J Brodie, E Perucca, P Ryvlin, E Ben-Menachem, H-J Meencke, Levetiracetam Monotherapy Study Group

3 registry-linked trialsAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Neurology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 94 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 5 pooled it
21.0field-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.

NCT00150735 phase3completednot on this map

A Multicenter, Double-blind, Randomized, Parallel Group, Positive-controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maximum of 121 Weeks in Subjects (≥ 16 Years) Newly or Recently Diagnosed as Suffering From Epilepsy, and Experiencing Partial or Generalized Tonic-clonic Seizures

TypeinterventionalSponsorUCB PharmaRan2002 to 2005Enrolled580ConditionsGeneralized EpilepsyArmsLEVETIRACETAM
NCT00150787 phase3completednot on this map

A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial.

TypeinterventionalSponsorUCB PharmaRan2003 to 2005Enrolled250ConditionsEpilepsy, Tonic-clonicArmsLEVETIRACETAM
NCT05450822 recruitingnot on this mapstarted 2022, after this paper: background citation

The BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy

TypeobservationalSponsorGitte Moos KnudsenRan2022 to 2031Enrolled550ConditionsEpilepsyArmsLevetiracetam, Levetiracetam Tablets, Lamotrigine tablet
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 5 syntheses or guidelines pooled it, 464 citations in OpenAlex.

  1. Pooled it
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  5. Epilepsy (partial).BMJ clinical evidence · 2011
    Pooled it
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34 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

M J BrodieEpilepsy Unit, Western Infirmary, Glasgow, G11 6NT, Scotland, UK. mjb2k@clinmed.gla.ac.uk
E Perucca
P Ryvlin
E Ben-Menachem
H-J Meencke
Levetiracetam Monotherapy Study Group
Urology Foundation · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe report the results of a prospective study of the efficacy and tolerability of levetiracetam, a new antiepileptic drug with a unique mechanism of action, in comparison with controlled-release carbamazepine as first treatment in newly diagnosed epilepsy.

methodsAdults with > or =2 partial or generalized tonic-clonic seizures in the previous year were randomly assigned to levetiracetam (500 mg twice daily, n = 288) or controlled-release carbamazepine (200 mg twice daily, n = 291) in a multicenter, double-blind, noninferiority, parallel-group trial. If a seizure occurred within 26 weeks of stabilization, dosage was increased incrementally to a maximum of levetiracetam 1,500 mg twice daily or carbamazepine 600 mg twice daily. Patients achieving the primary endpoint (6-month seizure freedom) continued on treatment for a further 6-month maintenance period.

resultsAt per-protocol analysis, 73.0% (56.6%) of patients randomized to levetiracetam and 72.8% (58.5%) receiving controlled-release carbamazepine were seizure free at the last evaluated dose (adjusted absolute difference 0.2%, 95% CI -7.8% to 8.2%) for > or =6 months (1 year). Of all patients achieving 6-month (1-year) remission, 80.1% (86.0%) in the levetiracetam group and 85.4% (89.3%) in the carbamazepine group did so at the lowest dose level. Withdrawal rates for adverse events were 14.4% with levetiracetam and 19.2% with carbamazepine.

conclusionsLevetiracetam and controlled-release carbamazepine produced equivalent seizure freedom rates in newly diagnosed epilepsy at optimal dosing in a setting mimicking clinical practice. This trial has confirmed in a randomized, double-blind setting previously uncontrolled observations that most people with epilepsy will respond to their first-ever antiepileptic drug at low dosage.

Indexed as

AdultAnticonvulsantsCarbamazepineDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodEpilepsyFemaleHumansLevetiracetamMalePiracetamTreatment OutcomeAnticonvulsantsCarbamazepineDelayed-Action PreparationsLevetiracetamPiracetam

Identifiers

PMID17283312
OpenAlexW2028500192

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.