8 results
* To assess the long-term safety and tolerability of ZX008.
The primary objective of Part 1 is the primary objective of the entire study.Part 1The primary objective of Part 1 is:* To evaluate the effect of ZX008 0.8 mg/kg/day versus placebo as adjunctive therapy for the treatment of uncontrolled seizures in…
The primary efficacy objectives of this two-cohort study are:o To demonstrate that ZX008 is superior to placebo as adjunctive therapy in the treatment of symptoms of Dravet syndrome in children and young adults based on change in the frequency of…
The objective of this study is to evaluate the safety and performance of the ROX Coupler in subjects with resistant hypertension.
In this trial we will study the utility of PerfusiX-Imaging for the identification of intersegmental planes during thoracoscopic segmentectomy.
In this trial we will study the utility of PerfusiX-Imaging for perfusion assessment of the gastric conduit in comparison with the standard of care.
Objectives for Part 1: Primary (Efficacy): To demonstrate that the efficacy of fenfluramine (ZX008) 0.8 mg/kg/day is superior to placebo as an adjunctive therapy for pediatric and adult subjects with CDD Secondary (Safety): To characterize the…
The study objective is to evaluate the efficiency of PerfusiX-Imaging compared to the current state of the art for perfusion measurements; indocyanine green fluorescence imaging. Also, feasibility and safety of PerfusiX-Imaging for perfusion…