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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

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

LECIG (levodopa, carbidopa, entacapone intestinal gel)

intestinal L-Dopa + entacapone (Lecigon®)

DRUG

Best oral medication

Best oral medication

Locations (4)

DRK gemeinnützige Krankenhausgesellschaft mbH Saarland

Saarlouis, Saarland, Germany

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