2 results
Approved WMOCompleted
The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…
Approved WMOCompleted
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…