Pharmacokinetics and safety of brivaracetam in neonates with repeated electroencephalographic seizures: A multicenter, open-label, single-arm study.

Objective: To evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) in neonates with repeated electroencephalographic seizures not controlled with previous antiseizure medications (ASMs).

Methods: Phase 2/3, multicenter, open-label, single-arm study (N01349/NCT03325439) in neonates with repeated electroencephalographic seizures (lasting ≥10 s) confirmed by video-electroencephalography, and inadequate seizure control with at least one ASM. A screening period (up to 36 h) was followed by a 48-h evaluation period during which patients received 0.

Efficacy and tolerability of brivaracetam monotherapy in childhood and juvenile absence epilepsy: An innovative adaptive trial design.

Objective: Despite introduction of several antiseizure medications over the past two decades, treatment options for childhood absence epilepsy (CAE) and juvenile absence epilepsy (JAE) remain limited. We report the innovative adaptive design of an ongoing phase 2/3 trial to evaluate efficacy, safety, and tolerability of brivaracetam (BRV) monotherapy in patients 2-25 years of age with CAE or JAE.

Methods: N01269 (ClinicalTrials.

Pharmacokinetics, safety, and tolerability of intravenous brivaracetam in pediatric patients with epilepsy: An open-label trial.

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.

Changes in functional organization and functional connectivity during story listening in children with benign childhood epilepsy with centro-temporal spikes.

Children with Benign Epilepsy with Centrotemporal Spikes (BECTS), despite high likelihood for seizure remission, are reported to have subtle difficulties in language and other cognitive skills. We used functional MRI and a story listening task to examine the effect of BECTS on patterns of activation and connectivity. Language and cognitive skills were assessed using standardized measures.

Development of the PedsQL™ Epilepsy Module: Focus group and cognitive interviews.

Unlabelled: Youth with epilepsy have impaired health-related quality of life (HRQOL). Existing epilepsy-specific HRQOL measures are limited by not having parallel self- and parent-proxy versions, having a restricted age range, not being inclusive of children with developmental disabilities, or being too lengthy for use in a clinical setting. Generic HRQOL measures do not adequately capture the idiosyncrasies of epilepsy.

Impact of frequency and lateralization of interictal discharges on neuropsychological and fine motor status in children with benign epilepsy with centrotemporal spikes.

Despite a positive prognosis for seizure remission, children with benign epilepsy with centrotemporal spikes (BECTS) have been reported to exhibit subtle neuropsychological difficulties. We examined the relationship between patterns of centrotemporal spikes (the typical electroencephalography [EEG] finding in BECTS) and neuropsychological and motor outcomes in children with new-onset BECTS. Thirty-four patients with new-onset BECTS (not taking antiepileptic medication) and 48 typically developing children participated in the study.

Methodological Issues in Predicting Pediatric Epilepsy Surgery Candidates Through Natural Language Processing and Machine Learning.

We describe the development and evaluation of a system that uses machine learning and natural language processing techniques to identify potential candidates for surgical intervention for drug-resistant pediatric epilepsy. The data are comprised of free-text clinical notes extracted from the electronic health record (EHR). Both known clinical outcomes from the EHR and manual chart annotations provide gold standards for the patient's status.

Longitudinal stability of interictal spikes in benign epilepsy with centrotemporal spikes.

Objective: To describe the natural history of electroencephalography (EEG) changes in patients with benign epilepsy with centrotemporal spikes (BECTS) over 1 year.

Methods: Centrotemporal spikes were visually evaluated based on 24-h ambulatory EEG studies to determine the total, left, right, and bilateral centrotemporal spikes patients were awake and asleep. These spike rates were then used to compare the entire night of sleep to the first 2 h of sleep, the repeatability of spike frequency over two recordings (done within days to weeks), and longitudinal changes in spike rate over 6 and 12 months.

The Pediatric Epilepsy Side Effects Questionnaire: Establishing clinically meaningful change.

The present study extends the utility of the Pediatric Epilepsy Side Effects Questionnaire (PESQ) by determining distribution-based minimally clinically important difference (MCID) scores. Participants (N=682) were youth (ages 2-25) with newly diagnosed and chronic epilepsy pooled from research and clinical data in the Comprehensive Epilepsy Center. Caregivers completed the PESQ.

Development and validation of the Pediatric Epilepsy Side Effects Questionnaire.

Objective: To develop and validate a measure of antiepileptic drug (AED) side effects in children with a variety of seizure types, treatments, and therapy durations.

Methods: Content for an initial 44-item measure was developed using the previously published Hague Scale and expert opinion from recognized pediatric epileptologists (n = 12) and caregivers of children with epilepsy (n = 21). The measure was completed by caregivers during routine clinic visits.

Functional magnetic resonance imaging reveals changes in language localization in children with benign childhood epilepsy with centrotemporal spikes.

In children with benign childhood epilepsy with centrotemporal spikes, centrotemporal spikes may cause language dysfunction via disruption of underlying functional neuroanatomy. Fifteen patients with benign childhood epilepsy with centrotemporal spikes and 15 healthy controls completed 3 functional magnetic resonance imaging (MRI) language paradigms; standardized cognitive and language assessments were also performed. For all paradigms, children with benign childhood epilepsy with centrotemporal spikes showed specific regional differences in activation compared to controls.

Ictal MEG onset source localization compared to intracranial EEG and outcome: improved epilepsy presurgical evaluation in pediatrics.

Purpose: Magnetoencephalography (MEG) has been shown a useful diagnostic tool for presurgical evaluation of pediatric medically intractable partial epilepsy as MEG source localization has been shown to improve the likelihood of seizure onset zone (SOZ) sampling during subsequent evaluation with intracranial EEG (ICEEG). We investigated whether ictal MEG onset source localization further improves results of interictal MEG in defining the SOZ.

Methods: We identified 20 pediatric patients with one habitual seizure during MEG recordings between October 2007 and April 2011.

Development and reliability of a correction factor for parent-reported adherence to pediatric antiepileptic drug therapy.

Purpose: Study aims were (1) to document and examine associations between parent-report and electronic monitoring (EM) of pediatric antiepileptic drug (AED) adherence, (2) to determine the sensitivity and specificity of parent-reported adherence, and (3) to develop a correction factor for parent-reported adherence.

Methods: Participants included 111 consecutive children with new-onset epilepsy (M(age) = 7.2 ± 2.

Even a single seizure negatively impacts pediatric health-related quality of life.

Purpose: Both a single seizure and chronic recurrent seizures (epilepsy) occur commonly in childhood. Although several studies have documented the impact of pediatric epilepsy on psychosocial functioning, such as health-related quality of life (HRQOL), no studies have examined the impact of a single seizure on HRQOL. The primary objectives of this study were: (1) to compare parent-proxy HRQOL in children with a single seizure and newly diagnosed untreated epilepsy to normative data and (2) to examine differences in parent-proxy HRQOL between children with single seizure and newly diagnosed untreated epilepsy.

One-month adherence in children with new-onset epilepsy: white-coat compliance does not occur.

Objectives: Adherence to antiepileptic drug therapy plays an important role in the effectiveness of pharmacologic treatment of epilepsy. The purpose of this study was to use an objective measure of adherence to (1) document patterns of adherence for the first month of therapy for children with new-onset epilepsy, (2) examine differences in adherence by demographic and epilepsy variables, and (3) determine whether treatment adherence improves for a short time before a clinic visit (eg, "white-coat compliance").

Methods: Participants included 35 children with new-onset epilepsy (mean age: 7.