14 results
We here propose a pilot immuno-PET study in active relapsing MS patients to investigate safety and sensitivity of 89Zr-rituximab in detecting CD20 positive (active) MS lesions and to assess inter-patient variability in 89Zr-rituximab biodistribition…
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times…
To evaluate the safety of E2007 given as adjunctive, long-term treatment in patients with refractory partial onset seizures with or without secondary generalization that completed the E2007-A001-206 or the E2007-G000-208 studies (revised per…
To assess the effect of teriflunomide in comparison to placebo, on frequency of multiple sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with interferon beta (IFN-β)
Primary objective: Study Part 1 : Single Ascending Dose: • To determine the clinical and biological safety and tolerability of oxathridine after an oral increasing single dose administration oxathridine in healthy male subjects. Study Part 2 : Proof…
To evaluate the safety and tolerability of ascending single and multiple oral doses of ADX71441 as compared to placebo in healthy volunteers.To evaluate the pharmacokinetics of orally administered single and multiple doses of ADX71441 and its…
The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…
Safety:* Evaluate the safety of AVXS-101 through incidence of adverse events (AEs) and/or serious adverse events (SAEs)* Evaluate the safety of AVXS-101 based on the change from baseline in clinical laboratory parametersEfficacy objectives will be…
The purpose of this study is to investigate how quickly and to what extend JZP-324 is absorbed and eliminated from the body (this is called pharmacokinetics). It will also be investigated how safe the new compound JZP-324 is and how well it is…
Primary:- To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects.Secondary:- To assess…
The objective of the present study is to assess the effect of HTL0009936 on cognitive performance in elderly subjects with below average cognitive function. The oral pharmacokinetics of HTL0009936 shows a significant degree of variability between…
The purpose of the study is to investigate the effect of CBD on specific ECG parameters. Importantly, it will be evaluated if there is a prolongation of the QT interval. When the QT interval is prolonged, repolarization of the heart is delayed. This…
The purpose of the study is to investigate to what extent CBD is safe and tolerated. It will also be investigated how quickly and to what extent CBD is absorbed and eliminated from the body (this is called pharmacokinetics). Furthermore the effect…
To assess PK of MPhs and MP.