23 results
Primary objective:the primary objective of the study is to evaluate the safety and to define the maximal tolerated dose or the maximal administered dose of CC-486 as a single agent, in combination with CBDCA or ABI-007 in subjects with relapsed or…
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…
Main Objective:Assess the efficacy of eculizumab as compared with placebo in the treatment of refractory gMG based on the improvement in the MG specific Activities of Daily Living profile (MG-ADL).Secondary Objectives: - Safety and tolerability of…
The objective of the study is to evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy.
The primary objective of the clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC. Secondary objective of the clinical part of EPISTOP is to…
The primary objective of this study is to assess the overall effectiveness of LCM (optimizedwithin the range of 200mg/day to 600mg/day) when added to a stable dose of LEV (in thelabel range of 1000mg/day to 3000mg/day) with withdrawal of the…
Assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
Assess the efficacy of eculizumab in adult patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
Objective: Primary objective: safety profile of LEV in neonates. Safety outcome parameters as liver, kidney and metabolic function, electrolytes, hemodynamic effects (heart rate/arrhythmia, arterial blood pressure/hypotension). Investigation of…
Comparison of single-dose pharmacokinetics of levetiracetam after rectal versus oral administration at healthy volunteers.
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…
Primary Objective: To assess whether early postoperative AED withdrawal improves cognitive function compared to late withdrawal.Secondary objectives: * To confirm safety of earlier AED withdrawal; we will assess eventual seizure freedom, seizure…
The primary objective of this study is to assess the noninferiority of ALXN1210 compared to eculizumab in adult patients with PNH who have never been treated with a complement inhibitor. Noninferiority will be claimed if after 26 weeks of treatment…
The primary objectives of this study are to establish the efficacy and safety of APL-2 compared to eculizumab in patients with PNH who continue to have Hb levels <10.5 g/dL despite treatment with eculizumab.
This study aims to investigate the biological efficacy and safety of eculizumab in patients with aneurysmal SAH.
- To evaluate effects of levetiracetam 2000 mg on single and paired pulse TMS-EMG and TMS-EEG in patients with epilepsy treated with mono-therapy levetiracetam, when compared to placebo (levetiracetam trough concentrations). - To evaluatethe effects…
To evaluate the safety and tolerability of crovalimab compared witheculizumab
The primary objectiveTo evaluate the efficacy of eculizumab in the treatment of pediatric refractory generalized myasthenia gravis (gMG) based on change from Baseline in the Quantitative Myasthenia Gravis score for disease severity (QMG).The…
Primary Objective: The primary objective for this study is to evaluate the efficacy of ABP 959 compared with that of eculizumab based on control of intravascular hemolysis.Secondary Objective: The secondary objective is to assess the safety,…
To evaluate the efficacy of crovalimab compared to eculizumab