Phase III Study of Intestinal Levodopa and Entacapone Gel Lecigon4 Compared to Best Oral Medication for Treating Parkinsons Disease Symptoms

What this Trial Is About

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.

Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease