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Objective This trial evaluated the short-term safety and tolerability, steady-state pharmacokinetics, and preliminary efficacy of brivaracetam oral solution in children aged 1 month to < 16 years with epilepsy. Methods This was a phase IIa, open-label, single-arm, fixed three-step dose escalation trial of 3-weeks duration (N01263; NCT00422422). Patients were taking one to three concomitant antiepileptic...
Differential effectiveness of antiepileptic drugs (AEDs) is more commonly determined by tolerability than efficacy. Cognitive effects of AEDs can adversely affect tolerability and quality of life. This study evaluated cognitive and EEG effects of lacosamide (LCM) compared with carbamazepine immediate-release (CBZ-IR). A randomized, double-blind, double-dummy, two-period crossover, fixed-dose study...
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...
Purpose: To examine the safety and tolerability of rapidly initiating adjunctive lacosamide via a single intravenous loading dose followed by twice‐daily oral lacosamide in lacosamide‐naive adults with partial‐onset seizures.
Methods: This open‐label, multicenter trial, enrolled patients with epilepsy who were taking 1–2 antiepileptic drugs (AEDs) in one of four sequential cohorts containing 25...
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