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Thyroid hormones play an essential role in central nervous system development, normal physiological brain function, and repair mechanisms. On one hand, thyroid hormone alterations influence cortical excitability, and on the other hand antiseizure medications (ASMs) are associated with alterations in thyroid hormone metabolism. Although this interaction has long been described, and epilepsy is a common...
Objective
To evaluate the long‐term safety and efficacy of add‐on cannabidiol (CBD) in patients with seizures associated with tuberous sclerosis complex (TSC) in the open‐label extension (OLE) of the randomized, placebo‐controlled phase 3 trial GWPCARE6 (NCT02544763). Results of an interim (February 2019 data cut) analysis are reported.
Methods
Patients who completed the randomized trial enrolled...
Objective
Pediatric epilepsy is often associated with diminished health‐related quality of life (HRQOL). Our aim was to establish the validity of the Pediatric Epilepsy Learning Healthcare System Quality of Life (PELHS‐QOL‐2) questions, a novel two‐item HRQOL prompt for children with epilepsy, primarily for use in clinical care.
Methods
We performed a multicenter cross‐sectional study to validate...
Objectives
This study was undertaken to estimate the cost‐effectiveness of deep brain stimulation (DBS) compared with vagus nerve stimulation (VNS) and care as usual (CAU) for adult patients with refractory epilepsy from a health care perspective using a lifetime decision analytic model.
Methods
A Markov decision analytic model was constructed to estimate the lifetime cost‐effectiveness of DBS...
Objective
This study was undertaken to determine the plasma concentration and pharmacokinetic variability of fenfluramine (FFA) and its main active metabolite norfenfluramine (norFFA) in relation to the prevalence of adverse effects in patients with refractory epilepsy treated with FFA. In addition, the interaction with concomitant antiseizure medications including stiripentol (STP) is studied.
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Objective
This study was undertaken to quantify epilepsy‐related costs of illness (COI) in Germany and identify cost‐driving factors.
Methods
COI were calculated among adults with epilepsy of different etiologies and severities. Multiple regression analysis was applied to determine any epilepsy‐related and sociodemographic factors that serve as cost‐driving factors.
Results
In total, 486 patients...
Objective
To evaluate the pharmacokinetics, safety, and tolerability of brivaracetam (BRV) as 15‐min intravenous (IV) infusion and bolus (≤2‐min injection).
Methods
EP0065 (ClinicalTrials.gov: NCT03405714) was a Phase 2, multicenter, open‐label trial in patients ≥1 month to <16 years of age with epilepsy. Patients received up to 5 mg/kg/day BRV (not exceeding 200 mg/day). Enrollment was sequential...
The maintenance of seizure control over time is a clinical priority in patients with epilepsy. The aim of this study was to assess the sustained seizure frequency reduction with adjunctive brivaracetam (BRV) in real‐world practice. Patients with focal epilepsy prescribed add‐on BRV were identified. Study outcomes included sustained seizure freedom and sustained seizure response, defined as a 100%...
Objectives
Refractory epilepsy is a diagnosis of recurrent seizures that requires multiple resources for optimal chronic management. The disease negatively impacts the lives of affected patients and families and poses an economic burden to the health care system. This study compares hospital costs between pediatric patients treated with antiseizure medications (ASMs) only and ASMs plus vagus nerve...
Objective
To estimate the timing of cannabidiol (CBD) treatment effect (seizure reduction and adverse events [AEs]) onset, we conducted a post hoc analysis of GWPCARE6 (NCT02544763), a randomized, placebo‐controlled, phase 3 trial in patients with drug‐resistant epilepsy associated with tuberous sclerosis complex (TSC).
Methods
Patients received plant‐derived pharmaceutical formulation of highly...
Objective
Only 50% of patients with new‐onset epilepsy achieve seizure freedom with their first antiseizure medication (ASM). A growing body of data illustrates the complexity of predicting ASM response and tolerability, which is influenced by age, sex, and comorbidities. Randomized data with sufficient resolution for personalized medicine are unlikely to emerge. Two potential facilitators of ASM...
Objective
This study was undertaken to calculate epilepsy‐related direct, indirect, and total costs in adult patients with active epilepsy (ongoing unprovoked seizures) in Germany and to analyze cost components and dynamics compared to previous studies from 2003, 2008, and 2013. This analysis was part of the Epi2020 study.
Methods
Direct and indirect costs related to epilepsy were calculated with...
Objective
The 1991 Medical Research Council (MRC) Study compared seizure relapse for seizure‐free patients randomized to withdraw vs continue of antiseizure medications (ASMs). We re‐analyzed this trial to account for crossover between arms using contamination‐adjusted intention to treat (CA ITT) methods, to explore dose‐response curves, and to validate predictions against external data. ITT assesses...
Objective
This study was undertaken to examine the prevalence of self‐reported experiences with abuse in pregnant women with epilepsy and the association between having experienced abuse and childbirth expectations, particularly the fear of childbirth.
Methods
We performed a cross‐sectional study of women with and without epilepsy enrolled in the Norwegian Mother, Father, and Child Cohort Study...
Objective
The US Food and Drug Administration recently issued a warning against the use of the antiseizure medication lamotrigine in people at risk of cardiac rhythm and conduction abnormalities. This study assessed the risk of cardiac morbidity and mortality in new users of lamotrigine.
Methods
In a Danish population‐based cohort study, we followed cohort members aged ≥15 years for the first 2...
Objective
This study was undertaken to develop consensus‐based recommendations for the management of adult and pediatric patients with new onset refractory status epilepticus (NORSE)/febrile infection‐related epilepsy syndrome (FIRES) based on best evidence and experience.
Methods
The Delphi methodology was followed. A facilitator group of nine experts was established, who defined the scope, users,...
Objective
The use of many antiseizure medications (ASMs) is limited due to pharmacoresistance and dose‐limiting side effects, suggesting an unmet need for novel therapeutic approaches. The neuropeptide galanin reduces seizures in several preclinical seizure and epilepsy models, but its clinical utility is limited due to rapid metabolism and poor blood–brain barrier penetration. The lead galanin analog...
Dravet syndrome (DS) is a rare, drug‐resistant, severe developmental and epileptic encephalopathy caused by pathogenic variants in the α subunit of the voltage‐gated sodium channel gene SCN1A. Hyperexcitability in DS results from loss of function in inhibitory interneurons. Thus sodium channel blockers are usually contraindicated in patients with DS as they may lead to disease aggravation. Cenobamate...
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