Extrait

Background and study aims The current widely-used treatment of Parkinson’s disease (PD) consists of dopamine replacement with levodopa or dopamine agonists. There is considerable debate about when and how to start treatment with drugs. Although current guidelines indicate that treating the symptoms of PD should be started when normal movement becomes difficult, most neurologists still delay starting treatment of these symptoms. This results in an acceptance of disability early in the disease. The results of recent studies suggest that early treatment with levodopa might have a delayed positive effect on PD symptoms. The aim of this study is to investigate whether early treatment with levodopa has a delayed positive effect on PD symptoms and functional health, improves the ability to (maintain) work; and• reduces the use of (informal) care, caregiver burden, and costs. Who can participate? Over 30 months, 446 patients with newly diagnosed PD that don’t need symptomatic treatment, as judged by the treating neurologist, will be included. What does the study involve? For 40 weeks, patients will receive either levodopa/carbidopa or a dummy (placebo) three times a day; for the next 40 weeks, all patients will receive levodopa/carbidopa three times a day. There are 8 assessments, all of which will be performed by trained research nurses. The study will measure disability, side effects, quality of life, ability to (maintain) work, the use of (informal) care, caregiver burden, and costs. What are the possible benefits and risks of participating? If the study shows a cost effective delayed positive effect of levodopa in newly diagnosed PD patients, treatment of symptoms should start as early as possible, i.e. immediately when the diagnosis is made. Subsequently, PD patients’ functional health and quality of life may improve substantially. This could prolong the normal level of social functioning and participation in the workforce. Levodopa has been the most commonly used medication for Parkinson's disease for over 40 years, with mostly minor side-effects. You can ask your neurologist for more information. Where is the study run from? Academic Medical Center (Netherlands) When is the study starting and how long is it expected to run for? August 2011 to December 2017 Who is funding the study? Netherlands Organisation for Health Research and Development (ZonMw, Netherlands), the Stichting ParkinsonFonds (patient organisation, Netherlands) and Parkinsonismen Vereniging (patient organisation, Netherlands) Who is the main contact? Dr Rob de Bie [email protected]

Critère d'inclusion

• Parkinson's disease

Liens

• isrctn
• ictrp