Trial reportEpilepsia2020
Effectiveness and tolerability of lacosamide as add-on therapy in patients with brain tumor-related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES).
Trial report in Epilepsia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02276053 (A Noninterventional Study of Vimpat®), which is not on this map. Cited by 21 papers.
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.
A Noninterventional Study of Vimpat® (Lacosamide) as Adjunctive Antiepileptic Drug Therapy in Patients With Brain Tumor-related Epilepsy
Who cites it
21 citing papers in PubMed, 51 citations in OpenAlex.
- Trial
- State of the art: glioma-associated epilepsy-bridging tumor biology and epileptogenesis.Neurological research and practice · 2025Review
- Symptom management in isocitrate dehydrogenase mutant glioma.Neuro-oncology practice · 2025Review
- Efficacy of perampanel by etiology in Japanese patients with epilepsy-subpopulation analysis of a prospective post-marketing observational study.Epilepsia open · 2024Observational
- Brain tumor-related epilepsy management: A Society for Neuro-oncology (SNO) consensus review on current management.Neuro-oncology · 2024Review
- Brain tumor-related epilepsy: an overview on neuropsychological, behavioral, and quality of life issues and assessment methodology.Frontiers in neurology · 2024Review
- The efficacy and safety of novel antiepileptic drugs in treatment of epilepsy of patients with brain tumors.Frontiers in neurology · 2024Review
- Seizure control by adding on other anti-seizure medication on seizure during levetiracetam administration in patients with glioma-related epilepsy.BMC cancer · 2023Article
- Seizure Management and Prophylaxis Considerations in Patients with Brain Tumors.Current oncology reports · 2023Review
- Effectiveness of Antiseizure Medication Duotherapies in Patients With Glioma: A Multicenter Observational Cohort Study.Neurology · 2022Observational
- Brain tumor related epilepsy: pathophysiological approaches and rational management of antiseizure medication.Neurological research and practice · 2022Review
- Lacosamide in monotherapy in BTRE (brain tumor-related epilepsy): results from an Italian multicenter retrospective study.Journal of neuro-oncology · 2022Article
- Prescription preferences of antiepileptic drugs in brain tumor patients: An international survey among EANO members.Neuro-oncology practice · 2022Article
- Chinese guideline on the application of anti-seizure medications in the perioperative period of supratentorial craniocerebral surgery.Therapeutic advances in neurological disorders · 2022Review
- Epilepsy treatment in neuro-oncology: A rationale for drug choice in common clinical scenarios.Frontiers in pharmacology · 2022Review
- Drug Therapeutic-Use Class Prediction and Repurposing Using Graph Convolutional Networks.Pharmaceutics · 2021Article
- Efficacy of antiepileptic drugs in glioma patients with epilepsy: a systematic review.Neuro-oncology practice · 2021Review
- The effectiveness of antiepileptic drug treatment in glioma patients: lamotrigine versus lacosamide.Journal of neuro-oncology · 2021Article
- Safety and Tolerability of Lacosamide in Patients With Epilepsy: A Systematic Review and Meta-Analysis.Frontiers in pharmacology · 2021Article
- Seizures, Edema, Thrombosis, and Hemorrhages: An Update Review on the Medical Management of Gliomas.Frontiers in oncology · 2021Review
Corrections and comments
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Authors and funding
11 authors at 9 institutions in 9 countries.
Funding
Abstract
objectiveTo evaluate the effectiveness and tolerability of lacosamide added to one or two antiepileptic drugs (AEDs) in the treatment of patients with brain tumor-related epilepsy (BTRE), and to evaluate patients' global impression of change and quality of life (QoL).
methodsThis was a prospective, multicenter, single-arm, noninterventional study with a 6-month observation period (EP0045; NCT02276053). Eligible patients (≥16 years old) had active BTRE secondary to low-grade glioma (World Health Organization grade 1 and 2) and were receiving treatment with one or two AEDs at baseline. Lacosamide was initiated by the treating physician in the course of routine clinical practice. Primary outcomes were 50% responders (≥50% reduction in focal seizure frequency from baseline) and Patient's Global Impression of Change (PGIC) at month 6. Secondary outcomes included seizure-free status and Clinical Global Impression of Change (CGIC) at month 6, change in QoL (5-Level EuroQol-5 Dimension Quality of Life Assessment) and symptom outcomes (MD Anderson Symptom Inventory-Brain Tumor) from baseline to month 6, and Kaplan-Meier estimated 6-month retention on lacosamide. Safety variables included adverse drug reactions (ADRs).
resultsPatients were recruited from 24 sites in Europe. Ninety-three patients received lacosamide (mean [standard deviation] age = 44.5 [14.7] years; 50 [53.8%] male; median baseline focal seizure frequency = five seizures/28 days [range = 1-280]), of whom 79 (84.9%) completed the study. At 6 months, 66 of 86 (76.7%) patients were 50% responders and 30 of 86 (34.9%) were seizure-free. Improvements on PGIC were reported by 49 of 76 (64.5%) patients. Based on CGIC, 52 of 81 (64.2%) patients improved. QoL and symptoms outcome measures remained stable. Kaplan-Meier estimated 6-month retention rate was 86.0% (N = 93). Fifteen (16.1%) patients reported ADRs; four (4.3%) had ADRs leading to discontinuation (N = 93). SIGNIFICANCE: Results of this prospective, noninterventional study suggest that add-on lacosamide is effective and generally well tolerated in patients with BTRE.
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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.