Trial reportArquivos de neuro-psiquiatria2021
Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy.
Trial report in Arquivos de neuro-psiquiatria, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.
- Efficacy of Levetiracetam in Patients With Pediatric Epilepsy: A Systematic Review and Meta-Analysis.Neurology · 2026Pooled it
- Pooled it
- Choice of antiseizure medications and associated outcomes in Medicare beneficiaries after acute ischemic stroke.Epilepsia · 2025Article
- Comparison of Levetiracetam Versus Sodium Valproate as a Monotherapy in Early Childhood Epilepsy.Cureus · 2025Article
- Choice of Epilepsy Anti-Seizure Medications and Associated Outcomes in Medicare Beneficiaries.medRxiv : the preprint server for health sciences · 2025Article
- Quantifying and controlling the impact of regression to the mean on randomized controlled trials in epilepsy.Epilepsia · 2023Article
- The effect of levetiracetam on depression and anti-oxidant activity in patients with epilepsy.Current journal of neurology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 9 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEpilepsy affects about 50 million people worldwide and around 30% of these patients have refractory epilepsy, with potential consequences regarding quality of life, morbidity and premature mortality.
objectiveThe aim of treatment with antiseizure medications (ASMs) is to allow patients to remain without seizures, with good tolerability. Levetiracetam is a broad-spectrum ASM with a unique mechanism of action that differs it from other ASMs. It has been shown to be effective and safe for treating adults and children with epilepsy.
methodsThis was a phase III, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of levetiracetam in children and adults (4-65 years) as an adjuvant treatment for focal-onset seizures. It was conducted among 114 patients undergoing treatment with up to three ASMs. The primary efficacy analysis was based on the proportion of patients who achieved a reduction of ≥ 50% in the mean number of focal seizures per week, over a 16-week treatment period. The patients were randomized to receive placebo or levetiracetam, titrated every two weeks from 20 mg/kg/day or 1,000 mg/day up to 60 mg/kg/day or 3,000 mg/day.
resultsLevetiracetam was significantly superior to placebo (p = 0.0031); 38.7% of the participants in the levetiracetam group and 14.3% in the control group shows reductions in focal seizures. Levetiracetam was seen to have a favorable safety profile and an adverse event rate similar to that of placebo.
conclusionCorroborating the results in the literature, levetiracetam was shown to be effective and safe for children and adults with refractory focal-onset epilepsy.
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Registered trials
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