Abstract
BackgroundThe aim of this study is to investigate if early treatment with levodopa has a beneficial disease modifying effect on Parkinson’s disease (PD) symptoms and functional health, improves the ability to (maintain) work, and reduces the use of (informal) care, caregiver burden, and costs. Additionally, cost-effectiveness and cost-utility of early levodopa treatment will be assessed.MethodsTo differentiate between the direct symptomatic effects and possible disease modifying effects of levodopa, we use a randomised delayed-start double-blind placebo-controlled multi-centre trial design. Patients with early stage PD whose functional health does not yet necessitate initiation of PD-medication will be randomised to either 40 weeks of treatment with levodopa/carbidopa 100/25 mg TID including 2 weeks of dose escalation or to 40 weeks placebo TID. Subsequently, all patients receive levodopa/carbidopa 100/25 mg TID for 40 weeks. There are 8 assessments: at baseline and at 4, 22, 40, 44, 56, 68, and 80 weeks. The primary outcome measure is the difference in the mean total Unified Parkinson’s Disease Rating Scale scores between the early- and delayed-start groups at 80 weeks. Secondary outcome measures are rate of progression, the AMC Linear Disability Score, side effects, perceived quality of life with the Parkinson’s Disease Questionnaire-39, the European Quality of Life-5 Dimensions (EQ-5D), ability to (maintain) work, the use of (informal) care, caregiver burden, and costs. 446 newly diagnosed PD patients without impaired functional health need to be recruited in order to detect a minimal clinical relevant difference of 4 points on the total UPDRS at 80 weeks.DiscussionThe LEAP-study will provide insights into the possible disease modifying effects of early levodopa.Trial registrationISRCTN30518857, EudraCT number 2011-000678-72
Highlights
The aim of this study is to investigate if early treatment with levodopa has a beneficial disease modifying effect on Parkinson’s disease (PD) symptoms and functional health, improves the ability to work, and reduces the use of care, caregiver burden, and costs
One concern is that levodopa could be toxic, this has never been supported by the results of clinical studies [5]
Levodopa-sparing strategies delay the onset of dyskinesias compared to levodopa monotherapy, sooner or later all patients need levodopa [2]
Summary
The aim of this study is to investigate if early treatment with levodopa has a beneficial disease modifying effect on Parkinson’s disease (PD) symptoms and functional health, improves the ability to (maintain) work, and reduces the use of (informal) care, caregiver burden, and costs. The core motor symptoms are caused by the degeneration of dopamine producing neurons [1, 2]. One concern is that levodopa could be toxic, this has never been supported by the results of clinical studies [5]. Another reason is the concern for side effects such as dyskinesias [1, 6]. Levodopa-sparing strategies delay the onset of dyskinesias compared to levodopa monotherapy, sooner or later all patients need levodopa [2]
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