The Infona portal uses cookies, i.e. strings of text saved by a browser on the user's device. The portal can access those files and use them to remember the user's data, such as their chosen settings (screen view, interface language, etc.), or their login data. By using the Infona portal the user accepts automatic saving and using this information for portal operation purposes. More information on the subject can be found in the Privacy Policy and Terms of Service. By closing this window the user confirms that they have read the information on cookie usage, and they accept the privacy policy and the way cookies are used by the portal. You can change the cookie settings in your browser.
PurposeThe aim of this study was to evaluate the effect of the antiepileptic drug lacosamide on the pharmacokinetics and pharmacodynamics of the anticoagulant warfarin.
MethodsIn this open‐label, two‐treatment crossover study, 16 healthy adult male volunteers were randomized to receive a single 25‐mg dose of warfarin alone in one period and lacosamide 200 mg twice daily on days 1–9 with a single...
PurposeCompare the pharmacokinetic (PK) profiles of immediate‐ and extended‐release formulations of topiramate (TPM) in healthy subjects following multiple dosing, and evaluate maintenance of topiramate exposures after switching formulations.
MethodsA randomized, open‐label, single‐center, two‐way crossover, multiple‐dose study comparing the steady‐state PK profile of once‐daily extended‐release...
PurposeInvestigate the pharmacokinetics of once‐daily (QD; 900 mg) and twice‐daily (BID; 450 mg) regimens of eslicarbazepine acetate (ESL) and BID (450 mg) regimen of oxcarbazepine (OXC) at steady state in healthy volunteers.
MethodsSingle‐center, open‐label, randomized, three‐way (n = 12) crossover studies in healthy volunteers.
Key FindingsMean eslicarbazepine Cmax,ss (in μm) following ESL QD...
PurposeAlthough there is a general paucity of published pharmacokinetic (PK) data for new antiepileptic drugs (AEDs), PK analyses of pooled data from clinical studies of perampanel have recently been presented. We present PK/pharmacodynamic (PD) analyses of pooled data from phase III studies of perampanel describing efficacy and safety as a function of exposure, in order to determine whether a predictable...
This randomized, double‐blind, placebo‐controlled, two‐way crossover study aimed to assess the pharmacokinetic interactions between brivaracetam 100 mg/day and a combination oral contraceptive (OC) containing 30 μg ethinylestradiol and 150 μg levonorgestrel. The study was performed in 28 healthy women over five 28‐day menstrual cycles: baseline (OC only), two treatment cycles with brivaracetam (50 mg...
ObjectiveTo determine the feasibility of administering a diazepam nasal spray formulation (diazepam‐NS) to adults with epilepsy during a generalized tonic–clonic seizure or in the postictal period following a tonic–clonic or other seizure type, to assess pharmacokinetics and to assess tolerability.
MethodsAn open‐label study was conducted in patients admitted to the epilepsy monitoring unit. Eligible...
ObjectiveTo evaluate the safety, tolerability, and pharmacokinetics (PK) of pregabalin as adjunctive therapy in children with refractory partial seizures.
MethodsThis was a phase 1, randomized, placebo‐controlled, parallel‐group, escalating‐dose, multiple‐dose study comprising a 7‐day, double‐blind treatment period and a single‐blind, single dose of pregabalin administered to all children on day...
The clinical pharmacology profile of a drug critically determines its therapeutics, and this review summarizes the characteristics associated with the antiepileptic drug (AED) perampanel. A PubMed literature search was performed for perampanel. Congress abstract data are included where necessary and Eisai Ltd provided access to unpublished data on file. After oral ingestion, perampanel is rapidly...
The antiepileptic drug (AED) perampanel is approved in ≥40 countries as adjunctive therapy for drug‐resistant partial seizures in patients with epilepsy. This post hoc analysis of pooled data from three phase III, double‐blind, randomized studies of perampanel examines between‐gender differences in perampanel efficacy and safety. Of the 1,478 subjects in the pooled analysis (719 male, 759 female),...
ObjectiveThis study was carried out to estimate the exposure of the central nervous system (CNS) to the antiepileptic drug (AED) lacosamide, under steady state conditions, in patients with epilepsy who take oral lacosamide alongside up to three other AEDs.
MethodsTwenty‐seven serum and cerebral spinal fluid (CSF) samples were collected from 21 patients receiving lacosamide for the treatment of epilepsy...
ObjectiveThe site of action for antiepileptic drugs (AEDs) is within the brain; however, cerebrospinal fluid (CSF) concentration is highly variable. Lacosamide (LCM) is approved by the U.S. Food and Drug Administration (FDA) for treatment of partial‐onset seizures in adults, and has linear pharmacokinetics in serum. Penetration across the blood–brain barrier (BBB) is unknown. This study aims to provide...
ObjectivesAn intravenous (IV) formulation of brivaracetam (BRV), a selective, high‐affinity ligand for synaptic vesicle protein 2A, has been developed. We investigated the safety, tolerability, and pharmacokinetics of adjunctive IV BRV administered as a bolus or infusion to adults with epilepsy.
MethodsA phase III, multicenter, randomized, four‐arm, parallel‐group study (NCT01405508) of patients...
Expediting pediatric access to new antiseizure drugs is particularly compelling, because epileptic seizures are the most common serious neurological symptom in children. Analysis of antiepileptic drug (AED) efficacy outcomes of randomized controlled trials, conducted during the past 20 years in different populations and a broad range of study sites and countries, has shown considerable consistency...
Allopregnanolone (5α‐pregnan‐3α‐ol‐20‐one) and its synthetic 3β‐methyl analog, ganaxolone, are positive allosteric modulators of synaptic and extrasynaptic γ‐aminobutyric acid (GABA)A receptors that exhibit antiseizure activity in diverse animal seizure models, including models of status epilepticus (SE). The 2 neuroactive steroids are being investigated as treatments for SE, including as a treatment...
Objective
Diazepam, administered by the intravenous, oral, or rectal routes, is widely used for the management of acute seizures. Dosage forms for delivery of diazepam by other routes of administration, including intranasal, intramuscular, and transbuccal, are under investigation. In predicting what dosages are necessary to terminate seizures, the minimal exposure required to confer seizure protection...
Generic antiepileptic drugs (AED) are significantly cheaper than brand name drugs, and may reduce overall health care expenditures. Regulatory bodies in Europe and North America require bioequivalence between generic and innovator drugs with regard to area under the plasma concentration–time curve (AUC) and peak plasma concentration (Cmax); strict cutoff values have been defined. The main issue is...
Objective
The objectives of this study were to investigate the effect of age on pharmacokinetic parameters of lamotrigine (LTG) and estimate parameter variability.
Methods
Patients (>18 years old) who were already on a steady‐state dose of LTG therapy with no interacting comedications were enrolled. Patients with significant cardiac disease, severe kidney dysfunction, or moderate‐to‐severe liver...
Objective
Increased activity of T‐type Ca2+ channels is linked to idiopathic generalized epilepsies, thus blocking these channels may be a new treatment option. ACT‐709478 is an orally available triple T‐type Ca2+ channel blocker. The aim of this first‐in‐man study was to investigate the pharmacokinetics, pharmacodynamics, tolerability, and safety of single doses of ACT‐709478 in healthy subjects...
Objective
To evaluate the pharmacokinetics of a purified oral cannabidiol (CBD) capsule administered with and without food in adults with refractory epilepsy.
Methods
Adult patients who were prescribed CBD for seizures, had localization‐related intractable epilepsy with ≥4 seizures per month, and qualified for Minnesota cannabis were enrolled. A single dose of 99% pure CBD capsules was taken under...
Objective
Pharmacokinetics (PK) of antiseizure drugs differ considerably between rats and humans. Rodents require larger and more frequent doses to maintain therapeutic drug levels. This study uses the antiseizure drug (ASD) carbamazepine (CBZ) to validate the application of a previously described automated drug delivery system for delivering chronic oral medication to rats.
Methods
Treatment‐naive,...
Set the date range to filter the displayed results. You can set a starting date, ending date or both. You can enter the dates manually or choose them from the calendar.