Actively Recruiting
Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease
Led by University Hospital Tuebingen · Updated on 2026-03-12
150
Participants Needed
3
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign informed consent before any study procedures
- Able to follow the study visit schedule and protocol requirements
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective contraception during the study
- Diagnosis of idiopathic Parkinson's disease including familial and genetic forms responsive to L-Dopa
- Age between 18 and 75 years
- Parkinson's disease onset before age 65
- Disease duration at least 5 years
- Stable oral medication regimen for at least four weeks before baseline
- Treatment with oral L-Dopa and non-ergot dopamine agonists
- Presence of motor fluctuations related to dopaminergic treatment
- Presence of neuropsychiatric (affective) fluctuations related to dopaminergic treatment
- Presence of behavioral hyperdopaminergic syndrome with clinically relevant neuropsychiatric abnormalities, including hypomanic symptoms or psychosis with retained insight
You will not qualify if you...
- Women who are pregnant or breastfeeding
- History of hypersensitivity to the study drug or similar compounds or excipients
- Participation in other clinical trials within the last three months
- Cognitive impairment with MoCA score below 21
- Acute paranoid psychosis without retained insight
- Severe depression by ICD-10 criteria
- Current active suicidality without self-distancing
- Contraindications for intestinal Levodopa therapy as per Lecigon information
- Gastrointestinal contraindications to PEG-J tube placement
- Tremor-dominant Parkinson's disease without dopaminergic response fluctuations
- Current device-assisted therapies such as DBS, LCIG/LECIG, or subcutaneous treatments, unless oral therapy has been resumed for at least three months
- Non-remitted malignancy
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Dresden, Germany
Actively Recruiting
2
Centre for Neurology, Department forNeurodegenerative Disease, and Hertie-Institute forClinical Brain Research
Tübingen, Germany, 72076
Actively Recruiting
3
Parkinson-Klinik Ortenau GmbH & Co. KG
Wolfach, Germany
Actively Recruiting
Research Team
D
Daniel Weiss, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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