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ObjectiveTo evaluate the efficacy and safety of adjunctive eslicarbazepine acetate (ESL) in patients with refractory partial‐onset seizures.
MethodsThis randomized, placebo‐controlled, double‐blind, parallel‐group, phase III study was conducted at 173 centers in 19 countries, including the United States and Canada. Eligible patients were aged ≥16 years and had uncontrolled partial‐onset seizures...
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...
Purpose: To evaluate the pharmacokinetics and tolerability of once‐daily eslicarbazepine acetate (ESL) and twice‐daily oxcarbazepine (OXC) and their metabolites in cerebrospinal fluid (CSF) and plasma following repeated oral administration.
Methods: Single‐center, open‐label, randomized, parallel‐group study in healthy volunteers. Volunteers in ESL group (n = 7) received 600 mg on days 1–3 and 1,200...
Purpose: To evaluate the efficacy and safety profile of eslicarbazepine acetate (ESL) added to stable antiepileptic therapy in adults with partial‐onset seizures.
Methods: Data from 1,049 patients enrolled from 125 centers, in 23 countries, in three phase III double‐blind, randomized, placebo‐controlled studies were pooled and analyzed. Following a 2‐week titration period, ESL was administered at...
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