10 results
To evaluate the efficacy of BRV at doses of 100 and 200mg/day compared to PBO as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant AEDsTo assess…
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…
The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to…
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 Objectives:• To assess the effects of VOR 200 mg BID on the steady-state PK of ATV administered as ATV/RTV300/100 mg QD in healthy subjects• To assess the effects of ATV/RTV 300/100 mg QD on the steady-state PK of VOR 200 mg BID inhealthy…
To evaluate the efficacy of BRV at the doses of 20, 50 and 100 mg/day in b.i.d. administration in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite optimal treatment with 1 to 2 concomitant AED(s),…
Primary objectiveTo evaluate if BRV influences the psychomotor and cognitive impairing effects of ethanolSecondary objectivesTo evaluate the potential PK interactions between BRV and ethanolTo evaluate the safety and tolerability of co-…
To describe the EMG activity of the pelvic floor muscles (PFM) with a bi-polar EMG probe and the MAPLe and effect on the registered EMG activity with the probes in relation to the contractions of the muscles surrounding the pelvic floor. To describe…
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…