6 results
The main goal of this study is to evaluate whether the performance in daily life grasping tasks, performed with a myoelectric prosthesis, increases when vibrotactile feedback about hand opening and grasping force is provided. Furthermore, the effect…
Provide proof-of-concept for the hypothesis that guanfacine diminishes cognitive side-effects in ER+ BC patients treated with adjuvant hormonal therapy. Secondary, provide data for power calculations in later studies.
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…
* 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…