Lisuride Patch to Treat Parkinson's Disease

Introduction: Parkinson's disease (PD) is a progressive degenerative disease of unknown etiology. Treatment is symptomatic and the most successful approach has been to replace the missing dopamine through administration of its precursor levodopa. As the disease progresses, the usefulness of this approach gradually diminishes, and motor complications become a source of significant disability. Although a number of pharmacological strategies have attempted to improve this situation, none has yet proven fully satisfactory. A novel transcutaneous formulation of the dopamine agonist lisuride will be used to test the ability of this approach to reduce levodopa-induced motor response complications. Objective: The objective of this study is to evaluate the risks and benefits of continuous dopaminomimetic replacement therapy in patients with advanced Parkinson's disease. Study population: Approximately 22 moderately advanced parkinsonian patients will be enrolled into a randomized, placebo-controlled, double-blind, proof-of-principle study, lasting approximately 16 weeks. Lisuride efficacy will be assessed through the use of validated motor function scales. Safety will be monitored by means of frequent clinical evaluations and laboratory tests. Anticipated Risks and Benefits: The potential risks associated with this study amount to only a minor increase over minimal risk and are primarily associated with adverse reactions to the medications involved. Lisuride has been approved for use in Europe for more than 20 years and has a wide margin of safety. Patients receiving drug could benefit from improvement of their clinical condition; those on placebo will also receive proper medical care that may lead to a better quality of life. Outcome Estimate and Potential Meaning for the Field: This study should further the understanding of mechanisms contributing to motor disability in patients with PD and thus lead to the development of improved therapeutic interventions for this disorder and for associated motor response complications.