3 results
To determine the efficacy endpoint whether the lack of ATP function will cause more appropriate but unnecessary shock therapy in patients with a S-ICD. Furthermore we will study the complication endpoint whether the S-ICD is superior to the TV-ICD…
Primary ObjectiveThe primary objective of the study is:• To compare the efficacy of 6.0, 7.5, and 9.0 g of FT218 to placebo in treating EDS in both NT1 and NT2 subjects as measured by mean sleep latency on the Maintenance of Wakefulness Test (MWT)…
* to describe the safety profile for qW, q2W and q3W regimens. * to determine the Maximum Tolerated Dose (MTD), if achieved (all regimens)* to describe the pharmacokinetics (PK) of single-agent RO6895882. Substudy BP28920/IMGThe study is designed to…