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Study of intestinal gel containing levodopa, carbidopa and entacapone to treat motor and behavioral symptoms in patients with Parkinson's disease

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating Parkinson's Disease, a progressive nervous system disorder that affects movement. The study evaluates a treatment called Lecigon, which is an intestinal gel containing three active substances: levodopa, entacapone, and carbidopa. These medications work together to help control the movement symptoms associated with Parkinson's Disease.

The purpose of this research is to determine if Lecigon therapy is more effective than standard medical treatment in managing certain behavioral and neuropsychiatric symptoms that can occur in Parkinson's Disease patients. These symptoms include mood changes and behavioral complications that may develop during the course of the disease.

The study treatment involves delivering the medication directly into the intestine as a gel. Patients will receive treatment for up to 12 months, during which time their symptoms and response to the medication will be monitored. The medication is designed to provide more consistent control of Parkinson's Disease symptoms compared to traditional oral medications.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your diagnosis of Parkinson's Disease will be confirmed, including verification that you have had the condition for at least 5 years

    Your current medication routine will be reviewed to ensure it has remained constant for the previous four weeks

    Your symptoms will be assessed, particularly focusing on changes in movement and behavior throughout the day

  2. Step 2

    Treatment assignment

    You will receive either Lecigon intestinal gel treatment or continue with your current best medical treatment

    The gel contains three active substances: entacapone, levodopa, and carbidopa

    If assigned to the gel treatment, you will receive it through intestinal administration

  3. Step 3

    Treatment period

    The treatment will continue for 6 months

    Your symptoms will be monitored using the Ardouin Behavioral Scale, which measures changes in behavior and movement

    Regular assessments will track your response to the treatment

  4. Step 4

    Final evaluation

    After 6 months, a final assessment will be conducted to measure changes in your symptoms

    The evaluation will focus particularly on movement control and behavioral changes

    The results will be compared to your initial assessment to determine the effectiveness of the treatment

Who can join the trial?

13 criteria

  • Must be able to understand and sign an informed consent document before any study procedures
  • Must be able to follow the study schedule and requirements
  • If able to have children, must use effective birth control methods during the study (such as hormonal contraception, IUD, or other approved methods)
  • Must agree not to share study medication with others
  • Must have a diagnosis of Parkinson's Disease, including familial or genetic forms that respond to L-Dopa (a common medication for Parkinson's)
  • Must be between 18 and 75 years old
  • Must have been diagnosed with Parkinson's disease before age 65
  • Must have had Parkinson's disease for 5 or more years
  • Must have been on stable oral medication for at least 4 weeks before starting the study
  • Must be taking L-Dopa and dopamine agonist medications (medications that help with Parkinson's symptoms)
  • Must experience changes in movement symptoms related to medication timing
  • Must experience mood changes related to medication timing
  • Must have certain behavioral symptoms measured by a special scale called the Ardouin Behavioral Scale, including mood changes and behavioral changes related to medication

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Presence of cognitive impairment (problems with thinking, memory, and decision-making)
  • History of neurosurgical procedures (brain surgery)
  • Presence of other neurological conditions besides Parkinson's Disease
  • Current participation in other clinical trials
  • Pregnancy or breastfeeding
  • Known allergy to any components of the study medication
  • Severe psychiatric disorders
  • Inability to comply with study procedures
  • Significant heart, liver, or kidney disease
  • Use of medications that could interfere with the study treatment
  • Deep Brain Stimulation (DBS) device in place
  • History of substance abuse in the past 6 months
  • Inability to provide informed consent
  • Unstable medical conditions that could affect study participation
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Investigated drugs

  • Lecigon

    is a combination medication containing levodopa and entacapone that is delivered directly into the intestine. It is used to treat Parkinson's disease symptoms. This intestinal delivery system helps provide more consistent levels of medication in the body compared to oral medications. The therapy aims to reduce fluctuations in movement control and help manage behavioral symptoms associated with Parkinson's disease.

  • Best Medical Treatment

    refers to the standard oral medications that patients with Parkinson's disease typically receive, which may include various combinations of medications adjusted to each patient's needs. This serves as the comparison treatment in the study.

What is already known about the treatment

  • Lecigon

    A combination intestinal gel medication containing levodopa and entacapone, specifically designed for advanced Parkinson's disease treatment. The medication is administered directly into the small intestine through a special pump system, providing continuous drug delivery that helps maintain stable dopamine levels in the brain. This innovative delivery method helps reduce motor fluctuations and "off" periods commonly experienced with traditional oral medications, while the addition of entacapone helps prolong levodopa's effectiveness by blocking its premature breakdown. Lecigon belongs to the class of dopaminergic medications and represents an advanced therapeutic option for patients who experience significant complications with conventional oral Parkinson's disease treatments.

  • Levodopa

    The primary active ingredient in Parkinson's disease treatment that works by converting into dopamine in the brain to replace the depleted natural dopamine levels. This medication is the most effective treatment for Parkinson's disease symptoms, helping to control movement problems, stiffness, and tremors. When administered as part of Lecigon therapy, levodopa is delivered directly to the intestine, allowing for more consistent absorption and better symptom control throughout the day.

  • Entacapone

    A COMT (Catechol-O-methyltransferase) inhibitor that works alongside levodopa to enhance its effectiveness in treating Parkinson's disease. This medication prevents the premature breakdown of levodopa in the body, allowing more of it to reach the brain where it's needed. When combined with levodopa in Lecigon, entacapone helps provide more consistent symptom control and potentially reduces the total amount of levodopa needed for effective treatment.

Investigated diseases

Parkinson's Disease - A progressive neurological disorder that affects movement and develops gradually, sometimes starting with a barely noticeable tremor in just one hand. The condition causes stiffness and slowing of movement, which tends to worsen over time. People with Parkinson's disease may have difficulty with walking and talking, and may experience gradual changes in their ability to perform everyday tasks. The disease occurs when nerve cells in the brain that produce dopamine become impaired or die. As the disease progresses, people may experience changes in their ability to walk, talk, and complete simple tasks.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521048-39-00Protocol codeINITIATE-LECIGEstimated enrolment150 patientsSponsorUniversitaetsklinikum Tuebingen AöR

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).