6 results
Primary:To evaluate the feasibility of using unconjugated rotigotine saliva concentrations as a surrogate for unconjugated rotigotine plasma concentrations.Secondary :To evaluate the effect of time of food intake on rotigotine concentrations in…
Primary objective:- To assess the long-term safety and tolerability of efgartigimod PH20 SC (efgartigimod co formulated with recombinant human hyaluronidase PH20 [rHuPH20] for subcutaneous [SC] administration).Secondary objectives:- To determine the…
The main objective is to assess the efficacy of the closed loop system at the home of the patient. Secondary objectives are to assess the safety of the new prototype while the telemonitoring intensity is being reduced during the trial; to…
The main objective of this study is to assess efficacy of the closed loop system in patients after total pancreatectomy. Secondary objectives are to assess the safety of the closed loop system; to determine the time that the control algorithm is…
Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…
Primary:To evaluate the long-term safety and tolerability of efgartigimod PH20 SC in participants with Generalized Myasthenia Gravis (gMG).Secondary:• To evaluate the impact of efgartigimod PH20 SC on disease severity• To evaluate the effect of…