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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Parkinson-Klinik Ortenau GmbH & Co. KG Wolfach Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Marienhospital Bottrop gGmbH Bottrop Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Dse Kvnvcwhthwr Samytxxsr Saarlouis Germany
Ugusfjkzuliviygjjuwbm Mnhkbqny Atl Munster Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
28.10.2025

Trial locations

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.

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 ID:
2025-521048-39-00
Protocol code:
INITIATE-LECIG
Trial Phase:
Therapeutic confirmatory (Phase III)

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