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

This study is a Phase III multicentric randomized controlled trial with parallel group design and waiting list in patients that have an indication to undergo intestinal L-Dopa + entacapone (Lecigon®) under the existing indication criteria (according to SmPC (Fachinformation) Lecigon®). As primary endpoint, we will analyze the difference of the pre-interventional baseline and 6-month follow-up on the "hyperdopaminergic symptoms" corresponding to section 3 of the "Ardouin Behavioural Scale" hypothesizing on the superiority of LECIG therapy compared to best medical treatment.

NCT Number	NCT07151378
Lead Sponsor	University Hospital Tuebingen
Conditions	PARKINSON DISEASE (Disorder)
Enrollment	150 participants
Start Date	2025-10-27
Primary Completion	2030-09-22 (estimated)
Study Completion	2030-09-22 (estimated)
Updated on ClinicalTrials.gov	2026-07-13