Long‐term safety and efficacy of lacosamide and controlled‐release carbamazepine monotherapy in patients with newly diagnosed epilepsy

Abstract

Objective

A large‐scale, double‐blind trial (SP0993; NCT01243177) demonstrated that lacosamide was noninferior to controlled‐release carbamazepine (carbamazepine‐CR) in terms of efficacy, and well tolerated as first‐line monotherapy in patients (≥16 years of age) with newly diagnosed epilepsy. We report primary safety outcomes from the double‐blind extension of the noninferiority trial (SP0994; NCT01465997) and post hoc analyses of pooled long‐term safety and efficacy data from both trials.

Methods

Patients were randomized 1:1 to lacosamide or carbamazepine‐CR. Doses were escalated (lacosamide: 200/400/600 mg/d; carbamazepine‐CR: 400/800/1200 mg/d) based on seizure ...

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The probability of seizures during continuous EEG monitoring in high‐risk neonates

Abstract

Objective

We evaluated the impact of monitoring indication, early electroencephalography (EEG), and clinical features on seizure risk in all neonates undergoing continuous EEG (cEEG) monitoring following a standardized monitoring protocol.

Methods

All cEEGs from unique neonates 34‐48 weeks postmenstrual age monitored from 1/2011‐10/2017 (n = 291) were included. We evaluated the impact of cEEG monitoring indication (acute neonatal encephalopathy [ANE], suspicious clinical events [SCEs], or other high‐risk conditions [OHRs]), age, medication status, and early EEG abnormalities (including the presence of epileptiform discharges and abnormal background continuity, ...

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Comparing the efficacy, exposure, and cost of clinical trial analysis methods

Abstract

This study aimed to compare three commonly used analysis methods for clinical trials in epilepsy in terms of statistical efficiency, nonefficacious exposure, and cost. A realistic seizure diary simulator was employed to produce 102 000 trials, which were analyzed by the 50%‐responder rate method (RR50), median percentage change (MPC), and time to prerandomization (TTP). Half the trials compared a placebo to a drug that was 20% better, and the other half compared two placebos. The former were used to calculate statistical ...

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Pediatric status epilepticus: Identification of prognostic factors using the new ILAE classification after 5 years of follow‐up

Abstract

Objective

Status epilepticus (SE) is the most common neurologic emergency in childhood. This study aimed to report on a large cohort of pediatric patients with SE, applying the International League Against Epilepsy (ILAE) Classification for SE to identify prognostic factors.

Methods

We included 173 children treated at “Bambino Gesù” Children’s Hospital in Rome for SE exceeding 30 minutes (mean age 4.43 ± 4.93 years old, median 2.28, interquartile range [IQR] 0.41‐7.32; follow‐up for a mean of 4.9 ± 3.4 years, median 8.75, IQR 4,58‐12.63). A multivariate model was constructed to ...

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Treatment of refractory and superrefractory status epilepticus with topiramate: A cohort study of 106 patients and a review of the literature

Abstract

Objective

Novel treatments are needed to control treatment‐resistant status epilepticus (SE). We present a summary of clinical cases where oral topiramate (TPM) was used in refractory SE (RSE) and superrefractory SE (SRSE).

Methods

A review of medical records was carried out to detect TPM administration in SE patients treated in Frankfurt and Marburg between 2011 and 2016. The primary outcome question concerned SE resolution after TPM initiation.

Results

In total, TPM was used in 106 of 854 patients having a mean age of 67.4 ± 18.1 years, 61 ...

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NREM sleep is the state of vigilance that best identifies the epileptogenic zone in the interictal electroencephalogram

Abstract

Objective

Interictal epileptiform anomalies such as epileptiform discharges or high‐frequency oscillations show marked variations across the sleep‐wake cycle. This study investigates which state of vigilance is the best to localize the epileptogenic zone (EZ) in interictal intracranial electroencephalography (EEG).

Methods

Thirty patients with drug‐resistant epilepsy undergoing stereo‐EEG (SEEG)/sleep recording and subsequent open surgery were included; 13 patients (43.3%) had good surgical outcome (Engel class I). Sleep was scored following standard criteria. Multiple features based on the interictal EEG (interictal epileptiform discharges, high‐frequency oscillations, ...

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Brainstem activity, apnea, and death during seizures induced by intrahippocampal kainic acid in anaesthetized rats

Abstract

Objective

To investigate how prolonged seizure activity affects cardiorespiratory function and activity of pre‐Bötzinger complex, leading to sudden death.

Methods

Urethane‐anesthetized female Long‐Evans rats were implanted with nasal thermocouple; venous and arterial cannulae; and electrodes for electrocardiography (ECG) and hippocampal, cortical, and brainstem recording. Kainic acid injection into the ventral hippocampus induced status epilepticus.

Results

Seizures caused hypertension, tachycardia, and tachypnea punctuated by recurrent transient apneas. Salivation increased considerably: in 11 of 12 rats, liquid with alkaline pH consistent with saliva was expelled from the ...

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Learning to see the invisible: A data‐driven approach to finding the underlying patterns of abnormality in visually normal brain magnetic resonance images in patients with temporal lobe epilepsy

Abstract

Objective

To find the covert patterns of abnormality in patients with unilateral temporal lobe epilepsy (TLE) and visually normal brain magnetic resonance images (MRI‐negative), comparing them to those with visible abnormalities (MRI‐positive).

Methods

We used multimodal brain MRI from patients with unilateral TLE and employed contemporary machine learning methods to predict the known laterality of seizure onset in 104 subjects (82 MRI‐positive, 22 MRI‐negative). A visualization approach entitled “Importance Maps” was developed to highlight image features predictive of seizure laterality in both the ...

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Scalp EEG spikes predict impending epilepsy in TSC infants: A longitudinal observational study

Abstract

Objective

To determine if routine electroencephalography (EEG) in seizure‐naive infants with tuberous sclerosis complex (TSC) can predict epilepsy and subsequent neurocognitive outcomes.

Methods

Forty infants 7 months of age or younger and meeting the genetic or clinical diagnostic criteria for tuberous sclerosis were enrolled. Exclusion criteria included prior history of seizures or treatment with antiseizure medications. At each visit, seizure history and 1‐hour awake and asleep video‐EEG, standardized across all sites, were obtained until 2 years of age. Developmental assessments (Mullen and Vineland‐II) were completed ...

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Hemispherectomy in adults and adolescents: Seizure and functional outcomes in 47 patients

Abstract

Objective

To examine longitudinal seizure and functional outcomes after hemispherectomy in adults and adolescents.

Methods

We reviewed 47 consecutive patients older than 16 years who underwent hemispherectomy between 1996 and 2016 at our center. Clinical, electroencephalographic (EEG), imaging, neuropsychological, surgical, and functional status data were analyzed.

Results

Thirty‐six patients were 18 years or older at surgery; 11 were aged between 16 and 18 years. Brain injury leading to hemispheric epilepsy occurred before 10 years of age in 41 (87%) patients. At a mean follow‐up of 5.3 postoperative years ...

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