Levodopa in early Parkinson's disease

The aim of this thesis, ‘Levodopa in early Parkinson’s disease’ was to investigate a) whether levodopa has a beneficial disease modifying effect in Parkinson’s disease (PD) in a clinical trial, and to assess the related treatment costs, b) which lessons can be drawn from the way the trial has been executed, and c) whether attitudes towards treatment of PD have changed after the results of the trial became available.
In the Levodopa in Early Parkinson’s disease (LEAP) trial, a total of 445 patients with early PD were randomly assigned; 222 to the early-start group and 223 to the delayed-start group. The trial showed that in early PD, levodopa/carbidopa 100/25 mg three times a day had no disease-modifying effect over 80 weeks. From an economic point of view, the trial suggests that early treatment with levodopa is not more expensive than delayed treatment with levodopa.
The results of an external assessment of the recruitment process suggest that the variations across the country in referrals and reasons of non-inclusion could indicate the presence of issues related to clinical equipoise, patient eligibility, or study presentation. This supports the integration of structured methods to analyze and continually improve the recruitment process, right from the beginning of a trial. Finally, a repeated survey showed that in the Netherlands in 2010 and in 2021, treatment for PD started mostly when patients experience disability, and that in the course of only one decennium, levodopa had become the treatment of first choice to start pharmacological treatment with.