Observational studyEpilepsia2015
A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study.
Observational study in Epilepsia, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01098162 (A Non-interventional Post-marketing Study, Evaluating Seizure Control and Tolerability of Vimpat® as Adjunctive Therapy to One Baseline Antiepileptic Drug in Epilepsy Patients With Partial-onset Seizures With or Without Secondary Generalization in Daily Clinical Practice in Germany), which is not on this map. Cited by 23 papers, 1 of them a synthesis 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.
A Non-interventional Post-marketing Study, Evaluating Seizure Control and Tolerability of Vimpat® as Adjunctive Therapy to One Baseline Antiepileptic Drug in Epilepsy Patients With Partial-onset Seizures With or Without Secondary Generalization in Daily Clinical Practice in Germany
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical Efficacy and Safety of Lacosamide as an Adjunctive Treatment in Adults With Refractory Epilepsy.Frontiers in neurology · 2021Pooled it
- PROVE: Retrospective, non-interventional, Phase IV study of perampanel in real-world clinical care of patients with epilepsy.Epilepsia open · 2022Trial
- Trial
- Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures.Neurology · 2019Trial
- Efficacy and safety of branded vs generic lacosamide in epilepsy: a retrospective real-world study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Observational
- Cardiac adverse events associated with lacosamide: a disproportionality analysis of the FAERS database.Scientific reports · 2024Article
- Effect of locosamide as an add-on therapy in the management of dissociative disorders.Bioinformation · 2024Article
- Antiseizure Medication-Induced Alopecia: A Literature Review.Medicines (Basel, Switzerland) · 2023Review
- Lacosamide as the first add-on therapy in adult patients with focal epilepsy: A multicenter real-world study.Frontiers in neurology · 2023Article
- The therapeutic effects of lacosamide on epilepsy-associated comorbidities.Frontiers in neurology · 2023Review
- Use of lacosamide in children: experience of a tertiary medical care center in Brazil.Arquivos de neuro-psiquiatria · 2022Article
- Article
- Safety and Tolerability of Lacosamide in Patients With Epilepsy: A Systematic Review and Meta-Analysis.Frontiers in pharmacology · 2021Article
- Genomic and clinical predictors of lacosamide response in refractory epilepsies.Epilepsia open · 2019Article
- Changes in drug load during lacosamide combination therapy: A noninterventional, observational study in German and Austrian clinical practice.Epilepsia open · 2019Article
- Lacosamide monotherapy in clinical practice: A retrospective chart review.Acta neurologica Scandinavica · 2018Article
- Review
- Lacosamide in patients with gliomas and uncontrolled seizures: results from an observational study.Journal of neuro-oncology · 2018Observational
- Clinical stabilisation with lacosamide of mood disorder comorbid with PTSD and fronto-temporal epilepsy.Acta bio-medica : Atenei Parmensis · 2017Article
- Epileptic seizure, as the first symptom of hypoparathyroidism in children, does not require antiepileptic drugs.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveEvidence for the efficacy and safety of adjunctive lacosamide in the treatment of partial-onset seizures (POS) was gained during placebo-controlled clinical trials in patients with treatment-resistant seizures who were taking one to three concomitant antiepileptic drugs (AEDs). The VITOBA study (NCT01098162) evaluated the effectiveness and tolerability of adjunctive lacosamide added to one baseline AED in real-world clinical practice.
methodsWe conducted a 6-month observational study at 112 sites across Germany. Adult patients (≥ 16 years) with POS received lacosamide adjunctive to only one baseline AED. Seizure frequency reduction at the end of the observation period was compared with a 3-month retrospective baseline period.
resultsFive hundred seventy-one patients received lacosamide at least once (Safety Set [SS]); 520 provided evaluable seizure records (Full Analysis Set [FAS]); and 499 took in-label dosages of lacosamide (up to 400 mg) and were evaluated for effectiveness (modified FAS). Median baseline seizure frequency was 2.0 per 28 days: 47.1% of patients (235/499, mFAS) took a concomitant sodium channel-blocking (SCB) AED; 38.1% (190/499) had only one lifetime AED; and 18.4% (92/499) were aged ≥ 65 years (mFAS). At the final visit, 72.5% (358/494) of patients showed a ≥ 50% reduction in seizure frequency from baseline, 63.8% (315/494) showed a ≥ 75% reduction, and 45.5% (225/494) were seizure-free. Seizure freedom rates were higher in patients aged ≥ 65 years (56.7%) compared with patients aged <65 years (43.1%), in patients with ≤ 5 years epilepsy duration (52.5%) versus >5 years duration (41.0%), and when added to first monotherapy (60.5%) rather than as a later therapy option. Treatment-emergent adverse events (TEAEs) were reported by 48.5% (277/571) of patients (SS), with a profile similar to that observed in pivotal trials; 466 of patients (81.6%, SS) continued lacosamide therapy after the trial. SIGNIFICANCE: These results suggest that lacosamide use, added to one concomitant AED, was effective at improving seizure control and was well tolerated in patients treated in routine clinical practice.
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