3 results
Primary Objective: Studying the phenomenon of tolerance by evaluating pharmacokinetic- and dynamic parameters, in patients receiving long-term ITB therapy.Secondary Objective(s): 1.To specify the intrathecal pharmacokinetics and -dynamics of…
Primary Efficacy Objective The primary efficacy objective is to determine the long-term efficacy of NCAP (Neurostimulation of the Cholinergic Anti-inflammatory Pathway) delivered by the implanted device as assessed by the Crohn*s Disease Activity…
Primary Efficacy ObjectiveThe primary efficacy objective is to determine the effect of NCAP delivered by the implanted device on clinical signs and symptoms of Crohn*s disease, as assessed by the Crohn*s Disease Activity Index (CDAI)Secondary…