Wolfach

Researchers are conducting a Phase III multicenter randomized controlled trial to study intestinal Levodopa plus Entacapone therapy (Lecigon4) in patients with Parkinson's disease. The trial aims to evaluate whether Lecigon therapy can better control hyperdopaminergic symptoms, which include behavioral and neuropsychiatric complications, compared to the best available oral medications. Patients eligible for the study have Parkinson's disease with motor and neuropsychiatric fluctuations and meet specific diagnostic and treatment history criteria. Participants are assigned to receive either the intestinal gel formulation of Levodopa, Carbidopa, and Entacapone (Lecigon4) or the best oral medication available. The therapy is administered according to existing indication criteria for Lecigon. The study uses a parallel group design with a waiting list control. The main treatment period lasts for six months, during which researchers monitor changes in hyperdopaminergic symptoms. During the study, participants undergo assessments including the Ardouin Behavioral Scale to measure hyperdopaminergic symptoms at baseline and after six months. Researchers also track medication adherence and monitor for side effects or complications related to Parkinson's disease and its treatment. Participants must be able to attend scheduled visits and comply with protocol requirements throughout the study period.

Parkinson's disease (PD) is a neurological disorder that worsens over time, with symptoms like tremors, stiffness, and slow movement. The speed of progression varies among individuals. This research studies how well foscarbidopa/foslevodopa works for adults in Germany who are at the early advanced stages of Parkinson's disease under normal medical care. Participants will receive foscarbidopa/foslevodopa through a subcutaneous infusion as prescribed by their doctors. Around 125 adult participants will be enrolled across about 20 sites in Germany. The study follows participants for up to 12 months with no expected extra burden beyond usual clinical visits. During the study, participants will attend routine hospital or clinic visits as part of their regular care. Researchers will measure changes in the time participants experience "OFF" periods, when symptoms return, over up to 12 months. This will help assess the drug's real-world effectiveness on motor symptoms, quality of life, psychosocial functioning, and work ability.