8 results
The primary objective is to evaluate the long-term safety and tolerability of BRV at individualized doses up to a maximum of 200mg/day in focal epilepsy subjects.The second objective is to evaluate the maintenance of efficacy of BRV over time.
Primary objective:To assess the BE under fasted conditions of BRV 10mg, 75mg, and 100mg oral tablets of commercial formulation vs BRV 50mg oral tablet(reference) of clinical development formulation,To assess the BA under fasted conditions of BRV…
Specific Aim #1: To evaluate the efficacy and safety of shortened-duration (6 weeks total) versus conventional duration (3 months total) anticoagulation for first-episode, provoked, acute venous thrombosis among children in whom thrombus resolution/…
The objective op this study is to answer the following questions:-Is thrombin generation increased after abrupt cessation of intravenous unfractionated heparin after discontinuation of CVVH?-Is there a difference in increase in thrombin generation…
Objectives1. to determine whether nebulization of heparin decreases coagulation activation in the pulmonary compartment (i.e. BAL fluid)2. to determine whether nebulization of heparin decreases pulmonary vascular permeability
This study has the purpose to assess the pharmacokinetic (the science determining the fate of substances administered to the human body), safety and efficacy of brivaracetam (the study drug) in neonates who have seizures that are not adequately…
Primary objective* To document the long-term safety and tolerability of BRVSecondary objective* To assess the efficacy of BRV during long-term exposureOther objectives* To explore direct cost parameters* To assess the effect of BRV on behavior using…
This study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic…