7 results
The objective of the study is to evaluate the efficacy and safety of a single dose of fosaprepitant when administered concomitantly with ondansetron, with or without dexamethasone, in subjects birth to 17 years of age receiving emetogenic…
The purpose of this current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in pediatric patients, from 6 months to 17 years of age,…
Primary Objectives:• To investigate the effects of a stable level of alcohol (0.6 g/L) on fMRI activation patterns in healthy male volunteers,• To investigate the effect of a stable level of morphine (80 nmol/L) on fMRI activation patterns in…
Primary objectiveTo determine the efficacy of chronic treatment with arimoclomol 1200 mg/day (400 mg TID) compared to placebo over 76 weeks in subjects with ALS as assessed with Combined Assessment of Function and Survival (CAFS).Secondary…
Primary Objectives:* To evaluate the effects of therapeutic and supratherapeutic plasma levels of arimoclomol on the heart rate-corrected QT interval (QTc).Secondary Objectives:* To evaluate the effect of arimoclomol on other ECG parameters: heart…
Primary objective: To investigate the pharmacokinetics (PK) of multiple doses arimoclomol in plasma en urine.To investigate and quantify metabolites of arimoclomol in plasma and urine (reported seperately)Secondary objective: To evaluate the safety…
Primary objective:To assess the long-term safety of arimoclomol treatment of ALS.Secondary objective:To evaluate the long-term efficacy of arimoclomol treatment of ALS.Exploratory objectives:Health-related quality of life* To evaluate the effect of…