9 results
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.
The objectives of the study are as follows:Primary:• Part 1: To assess the pharmacokinetics and relative bioavailability of three different formulations of PA101 (4% cromolyn sodium with and without mannitol, and 6% cromolyn sodium without mannitol…
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…
Primary:* To determine the efficacy profile of PA101 delivered via a high efficiency nebulizer (eFlow®,PARI) in comparison with placebo following 6 weeks of treatment in patients with indolentsystemic mastocytosis (ISM) who are symptomatic despite…
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…
- 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…
The objective of the study is to assess the long-term safety and efficacy of intravenous ATB200 co-administration with oral AT2221 in adult subjects with late-onset Pompe disease.