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RECRUITING
NCT07151378
PHASE3

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

Sponsor: University Hospital Tuebingen

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-10-27

Completion Date

2030-09-22

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

LECIG (levodopa, carbidopa, entacapone intestinal gel)

intestinal L-Dopa + entacapone (Lecigon®)

DRUG

Best oral medication

Best oral medication

Locations (3)

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

Dresden, Germany

Centre for Neurology, Department forNeurodegenerative Disease, and Hertie-Institute forClinical Brain Research

Tübingen, Germany

Parkinson-Klinik Ortenau GmbH & Co. KG

Wolfach, Germany