Parkinson's Disease Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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