Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous Infusion
The aim of the study is to evaluate the long-term efficacy, local tolerability and safety of Lisuride applied as subcutaneous infusion compared to placebo in patients with advanced Parkinson's disease with motor fluctuations and "OFF" periods refractory to conventional treatment.
Drug: Continuous Subcutaneous Lisuride Infusion
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Double-blind, Placebo-controlled, Randomized, Multicentre Phase II/III Study to Evaluate the Efficacy and Safety of Lisuride, Applied Subcutaneously by Means of a Minipump in Patients With Advanced Parkinson's Disease Refractory to Conventional Oral Therapy|
- Change from baseline B0 to T6 in total daily "OFF-time and ON-time with troublesome dyskinesia
- Secondary objectives are to evaluate quality of life, quality of sleep, UPDRS Score
- clinical global impression, safety and tolerability.
- After the double-blind period, long-term efficacy of lisuride will be assessed for further 2 years in an open-label extension of the study
|Study Start Date:||July 2006|
The current CALIPSO study investigates the efficacy of a continuous lisuride infusion against the optimized previous oral therapy in patients experiencing motor fluctuations with OFF periods and/or strenuous dyskinesias of more than four hours per day.
The controlled core study is scheduled to last six weeks. Within the study the previous oral therapy will either be continued in a capsule/blinded design (while a placebo infusion is going on concurrently) or the oral therapy is substituted by lisuride infusion (while placebo capsules are administered at the same time).
After the controlled core study all patients whose condition has not worsened during the study (meaning those patients of the placebo infusion group as well, who were treated during the core study just as they were before), will be given the chance to continue with the infusion therapy with lisuride in an open extension phase.