The expanded approval was supported by extrapolated efficacy data from placebo-controlled studies in adults with partial-onset seizures.
The prevalence of major congenital malformations in offspring who are prenatally exposed to antiepileptic drugs is highest among those exposed to carbamazepine, phenobarbital doses of >80 mg/day, valproate of ≤650 mg/day, and levetiracetam at 250 to 4000 mg/day.
The investigators concluded that these findings should help to identify targets for intervention to reduce the overall time to treatment in this population.
The approval was based on a 12-week, double-blind, placebo-controlled study (N=295) in pediatric patients 4-17 years of age.
The approval is specifically for bilateral anterior thalamic nucleus stimulation and is based on results from the SANTE study (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy).
Although most adults with epilepsy report taking epilepsy medication, less than half of those report having their seizures controlled.
Ventriculomegaly, Polymicrogyria Predict Epilepsy Risk Among Pediatric Patients With Cytomegalovirus InfectionsMay 04, 2018
Investigators retrospectively reviewed the patients' medical records and MRI images and assessed the associations between the MRI findings and neurologic outcomes, specifically neurodevelopmental achievement, epilepsy, and sensorineural hearing loss.
Researchers evaluated the use of genetic screening to identify individuals who are at risk for carbamazepine-induced cutaneous adverse drug reactions.
Investigators conducted a population-based study to assess risk and cause of unnatural mortality in individuals with epilepsy.
Clinicians should conduct a medical evaluation as soon as suspicious symptoms are reported and discontinue lamotrigine if HLH is suspected.
Researchers evaluated the incidence of treatment-emergent adverse events in pediatric patients taking eslicarbazepine acetate with other antiepileptic drugs to better understand tolerability profiles.
Researchers conducted post-hoc analysis of data derived from 2 randomized, placebo-controlled trials to determine the safety and tolerability of eslicarbazepine in pediatric patients with partial-onset seizures not responsive to treatment with ≤2 antiepileptic drugs.
Prior studies have suggested that women with epilepsy who are seizure free ≥9 months prior to pregnancy have a high likelihood of remaining seizure free during pregnancy.
In the event where electroencephalograms featured either seizures or seizure-like patterns, nonexpert medical students who auditorily reviewed the electroencephalograms rated samples as seizures with a higher degree of specificity vs experts or nonexpert medical students.
Research was conducted to identify an association between the use of serotonin reuptake inhibitors and obstructive sleep apnea in a population of individuals with depression with or without epilepsy.
Cannabidiol may be effective as add-on treatment for drop seizures associated with Lennox-Gastaut syndrome.
The FDA has approved Afinitor Disperz for the adjunctive treatment of patients aged ≥2 years with TSC-associated partial-onset seizures.
The risk of unnatural death is increased among people with epilepsy.
Because of the small size of the study sample, the findings may be limited to this patient population and may be hard to generalize across all pediatric patients with Dravet syndrome.
The small sample size included in the study precludes the ability to make generalized statements about electroencephalogram pattern characteristics in the entire pediatric patient population with BECTS.
Best diagnostics and evidence-based treatments should be used from the start of the disease.
Exposure to sodium valproate or a combination of antiepileptic drugs in utero is associated with worse attainment on national educational tests.
The proposed pediatric indications are based on a 2018 Draft Guidance that supports extrapolating efficacy data of approved drugs to treat POS in adults to pediatric patients aged ≥4 years.
The adjusted analysis also demonstrated that the code stroke system was associated with a decreased risk for post-stroke epilepsy within 5 years of stroke.
The registers used in this study did not collect information on whether individuals with epilepsy were actually responsible for the transportation accidents.
Before we begin to rely more heavily on technology for seizure detection, clinician-patient trust needs to improve.
Pharmaceutical-grade CBD used as adjunctive therapy in patients with pediatric-onset drug-resistant epilepsy may reduce the frequency of seizures.
The findings are limited to the 50 most-prescribed non-epilepsy drugs assessed in this Medicare population and may not generalize to non-Medicare beneficiaries who receive other non-epilepsy drugs.
Cannabinoids are effective as an adjunctive treatment for reducing seizure frequency in pediatric-onset treatment-resistant epilepsy.
Investigators sought to validate a tool to identify post-stroke seizure risk.
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