Wolfach

This research aims to evaluate intestinal Levodopa plus entacapone therapy Lecigon4 in patients with Parkinsons disease who require this treatment based on existing guidelines. The study is a Phase III randomized controlled trial comparing Lecigon4 to the best available oral medication. The primary goal is to assess whether Lecigon4 is superior in reducing hyperdopaminergic symptoms measured by the Ardouin Behavioral Scale after six months. Participants are randomly assigned to one of two groups those continuing best oral medication and those receiving Lecigon4 as an intestinal gel combining levodopa, carbidopa, and entacapone. The trial uses a parallel group design with a waiting list component. Treatment is given according to established dosing criteria and patients are followed for at least six months to monitor effects. During the study, participants undergo regular assessments including behavioral evaluations with the Ardouin Behavioral Scale to track hyperdopaminergic syndrome changes. Safety and adherence to therapy are monitored throughout. The trial excludes patients with severe cognitive impairment or other contraindications. Total participation covers screening, treatment, and follow-up up to six months, with the primary outcome measured at that time.

Parkinsons disease is a neurological condition that affects the brain and worsens over time, with symptoms like tremors, stiffness, and slow movement. Researchers are evaluating how effective foscarbidopafoslevodopa is in treating adult German participants who are in the early stages of advanced Parkinsons disease under routine clinical care. This observational study includes about 125 adults prescribed this treatment by their doctors in Germany. Participants will receive foscarbidopafoslevodopa via subcutaneous infusion as their physician prescribes, following local label instructions. The treatment is given during usual clinical visits without extra interventions specifically for the study. Participants will be followed for up to 12 months to monitor their treatment experience and outcomes. During the study, participants will attend regular hospital or clinic visits as part of their routine care. Researchers will assess changes in OFF time, which refers to periods when Parkinsons symptoms return or worsen, measuring this for up to 12 months. There is no expected additional burden beyond standard care, and participant safety and quality of life will be monitored throughout the study period.