RecruitingPhase 3NCT07151378

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


Sponsor

University Hospital Tuebingen

Enrollment

150 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a gel-form medication (Lecigon) delivered directly into the small intestine for people with Parkinson's disease who experience both movement and psychiatric side effects from their current dopamine medications. The goal is to see whether this delivery method can reduce these fluctuating symptoms. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with Parkinson's disease for at least 5 years, with disease onset before age 65 - You are currently taking levodopa and a dopamine agonist (non-ergot type) - You experience motor fluctuations (times when your medication wears off) AND psychiatric/mood fluctuations tied to your medication - You show signs of behavioral problems related to too much dopamine (such as compulsive behaviors or mild psychosis) but still have insight into your condition - Your oral medications have been stable for the past 4 weeks - You are willing to use reliable contraception if applicable **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have severe cognitive impairment (low score on memory tests) - You have active psychosis without self-awareness, severe depression, or active suicidality - You have already had a device implanted for Parkinson's treatment (e.g., deep brain stimulation or intestinal drug pump) - You have a history of allergic reaction to the study drug - You have untreated cancer or contraindications to intestinal tube placement - You participated in another clinical trial in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLECIG (levodopa, carbidopa, entacapone intestinal gel)

intestinal L-Dopa + entacapone (Lecigon®)

DRUGBest 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

View Full Details on ClinicalTrials.gov

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NCT07151378


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