12 results
The primary objective of this trial is to determine whether different types of anaesthesia [regional versus general] given to infants undergoing inguinal hernia repair result in equivalent neurodevelopmental outcomes. Secondary objectives are to…
The primary objective of this study is to evaluate the efficacy (clinical and MRI) of switching tonatalizumab compared to receiving interferon β1-a or glatiramer acetate.
The objective of this study is to determine if patients without heart failure receiving Sevoflurane have a different myocardial ischemia-reperfusion injury and/or systemic inflammatory response than patients who do not receive Sevoflurane.
The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…
Natalizumab (Tysabri®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes
The primary objective of the study is the functional improvement with one point or more on the modified Rankin scale after the 12th week of natalizumab (compared to baseline).
Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…
4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…
Our main objective is to prove that extending dose intervals guided by serum concentrations of natalizumab, will not result in radiological or clinical disease activity.
Primary Objectives1. To assess the safety and tolerability of ascending doses of a single IV injection of OTL-0382. To assess the efficacy of ascending doses of a single IV injection of OTL-038 in detecting ovarian, renal cell and endometrial cancer…
Primary objective:To assess the safety, tolerability and pharmacokinetics of a single IV dosages of OTL-038. Selected doses of OTL-038 will be studied in the absence and presence of prophylactic treatment with the antihistamine clemastine to be…
The main objective of the study is to investigate whether the strong clinical effects of natalizumab in RRMS can be explained by enhanced functional adaptation mechanisms of the brain and whether enhanced functional reorganisation is sustained over…
Primary Objective: Our objective is to validate the safety, measured by radiological disease activity, of personalized extended interval dosing of natalizumab to >=6 weeks (with an aim natalizumab trough concentration of 5 µg/ml) in a large…