Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2030-09-22

Target enrollment:

Participant gender:

Summary

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.

Phase:

PHASE3

Details

Lead Sponsor:

University Hospital Tuebingen

Treatments:

Carbidopa
Levodopa