13 results
The objectives of this multi-centre, double-blind, randomized, 2-parallelgroups study are to investigate the efficacy, safety and tolerability of levetiracetam (LEV) monotherapy 15-60mg/kg/day versus valproic acid (VPA) monotherapy 10-40mg/kg/day in…
Primary:The primary objective is to determine the safety and tolerability of the combination treatment, i.e. GCb, VPA and GCV, by evaluation of adverse events (AE*s) serious adverse events (SAE*s) and all clinically significant changes in clinical…
The study objectives are:- to characterize the biotransformation pathways, the routes and rates of excretion, and total recovery of the 14C-labeled research medication and its radiolabeled metabolites- to characterize the pharmacokinetics (PK) of…
The primary objectives for Part 1:-To determine the recommended Phase II dose of RO5424802 to be used in Part 2 of the study-To evaluate the safety and tolerability of 600mg and 900mg doses of RO5424802 administered twice daily to subjects with…
Primary Objective- To investigate the ability of TMS-EEG measures to detect effects on cortical excitability of valproic acid, levetiracetam and lorazepam in healthy subjects- To investigate the ability of TMS-EMG measures to detect effects on…
The primary objective is to assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST v1.1. The secondary objectives are to evaluate secondary measures of clinical efficacy including disease control, progression-free…
The longitudinal assessment of the BAFi pyrimethamine and of the HDACi valproic acid on the HIV reservoir size in HIV patients on antiretroviral therapy.
The primary objective will be a prolonged mPFS for the TDM-guided dosing cohort versus the standard fixed dosing cohort in the group of patients with an alectinib Cmin below the threshold of< 435 ng/mL. The secondary objectives are…
The overall objectives of this study are to evaluate the efficacy and safety of multiple therapies in patients with locally advanced, unresectable, Stage III NSCLC who are selected according to biomarker status as identified by tissue-based testing.…
Primary objective:-To confirm that the Event-Free Survival (EFS) in patients >= 3 years of age with WHO grade IV/CNS WHO grade 4 and WHO grade III/CNS WHOgrade 3 diffuse high grade gliomas as well as diffuse high grade gliomas without a…
Primary objective:To assess whether hydralazine in combination with valproate is effective in treating the symptoms of narcolepsy.Secondary objectives:- To assess the safety of treating NT1 patients with hydralazine in combination with valproate.-…
Study MX39795 will compare the efficacy and safety of molecularly-guided therapy versusstandard platinum-containing chemotherapy in patients with poor prognosis cancer of unknown primary site(CUP; non-specific subset) who have achieved disease…
The aim of this prospective proof-of-concept study is to increase the expression of the SSTR2 in NET patients with negative or low expression to levels amenable for somatostatin analogue treatment through the use of epigenetic drugs.