Trial reportArchives of neurology2012
Results of phase 2 safety and feasibility study of treatment with levetiracetam for prevention of posttraumatic epilepsy.
Trial report in Archives of neurology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01463033 (Pilot), which is not on this map. Cited by 38 papers, 5 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.
Pilot: Levetiracetam to Prevent Post-Traumatic Epilepsy
Who cites it
38 citing papers in PubMed, 5 syntheses or guidelines pooled it, 97 citations in OpenAlex.
- Guidelines for Seizure Prophylaxis in Adults Hospitalized with Moderate-Severe Traumatic Brain Injury: A Clinical Practice Guideline for Health Care Professionals from the Neurocritical Care Society.Neurocritical care · 2024Guideline
- Levetiracetam for Seizure Prophylaxis in Neurocritical Care: A Systematic Review and Meta-analysis.Neurocritical care · 2022Pooled it
- Effectiveness of antiseizure medications therapy in preventing seizures in brain injury patients: A network meta-analysis.Frontiers in pharmacology · 2022Pooled it
- Levetiracetam Versus Phenytoin for Seizure Prophylaxis Following Traumatic Brain Injury: A Systematic Review and Meta-Analysis.CNS drugs · 2016Pooled it
- Pharmacological treatments for preventing epilepsy following traumatic head injury.The Cochrane database of systematic reviews · 2015Pooled it
- Seizure prophylaxis in glioma surgery: a synopsis from the SPRING RCT.Health technology assessment (Winchester, England) · 2026Trial
- Results of phase II levetiracetam trial following acute head injury in children at risk for posttraumatic epilepsy.Epilepsia · 2013Trial
- Results of phase II pharmacokinetic study of levetiracetam for prevention of post-traumatic epilepsy.Epilepsy & behavior : E&B · 2012Trial
- Levetiracetam for Seizure Prophylaxis after Traumatic Brain Injury: A Severity-Stratified Cohort Study of 51,000 Patients.Annals of neurology · 2026Article
- Article
- Seizure prophylaxis in glioma surgery (SPRING): A multi-center, unblinded, randomized trial.Neuro-oncology practice · 2026Article
- Article
- Epilepsy as a dynamic disease: Toward actionable, individualized seizure risk prediction.Epilepsia · 2025Review
- New epilepsy therapies in development.Nature reviews. Drug discovery · 2024Review
- Antiseizure medication ≤48 hours portends better prognosis in new-onset epilepsy.European journal of neurology · 2024Article
- Initial clinical evidence on biperiden as antiepileptogenic after traumatic brain injury-a randomized clinical trial.Frontiers in neurology · 2024Article
- Association of Early Seizure Prophylaxis With Posttraumatic Seizures and Mortality: A Meta-analysis With Evidence Quality Assessment.Neurology. Clinical practice · 2023Review
- Effect of levetiracetam and valproate on late-onset post-traumatic seizures.Acta epileptologica · 2023Article
- Early post-traumatic seizures in hospitalized patients with traumatic brain injury.Acta neurologica Scandinavica · 2022Article
- Levetiracetam Suppresses the Infiltration of Neutrophils and Monocytes and Downregulates Many Inflammatory Cytokines during Epileptogenesis in Pilocarpine-Induced Status Epilepticus Mice.International journal of molecular sciences · 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
14 authors at 2 institutions in 1 country.
Funding
Abstract
objectivesTo evaluate the safety and tolerability of treatment with levetiracetam and determine the trough levels of levetiracetam in patients with traumatic brain injury (TBI) who are at high risk for posttraumatic epilepsy (PTE).
designOpen-label, nonrandomized phase 2 study with 2 arms comparing levetiracetam treatment vs observation.
settingTwo level 1 trauma centers. PATIENTS: A total of 422 participants 6 years or older with TBI who have a 20% risk for PTE were screened. Of these participants, 205 (48.6%) were eligible. A total of 126 participants were enrolled: 86 adults and 40 children. A total of 66 participants were in the treatment group (46 adults and 20 children), and a total of 60 participants were in the observation group (40 adults and 20 children). Participants presenting within 8 hours after TBI received treatment, and those presenting more than 8 to 24 hours after TBI did not.
interventionTreatment with levetiracetam (55 mg/kg/d) for 30 days starting within 8 hours after injury.
main outcome measuresNumber of adverse events, mood score, number of infections, trough level of levetiracetam, and PTE.
resultsOf the 66 participants treated with levetiracetam, 2 (3%) stopped treatment owing to toxicity (somnolence). The most common adverse events were fatigue, headache, and somnolence. Mood scores and number of infections did not differ between the treatment and observation groups. Mean trough levels of levetiracetam on days 2 to 30 ranged from 19.6 to 26.7 μg/mL. At 2 years, 13 of 86 adults (15.1%) and 1 of 40 children (2.5%) developed PTE. At 2 years, 5 of 46 treated adults (10.9%) and 8 of 40 untreated adults (20.0%) developed PTE (relative risk, 0.47; P=.18).
conclusionTreatment with 55 mg/kg/d of levetiracetam (a dose with an antiepileptogenic effect on animals) for patients with TBI at risk for PTE is safe and well tolerated, with plasma levels similar to those in animal studies. The findings support further evaluation of levetiracetam treatment for the prevention of PTE.
trial registrationclinicaltrials.gov Identifier: NCT01463033.
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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.