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New treatment option for PARKINSON DISEASE (Disorder)
Official title Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease
ClinicalTrials.gov ID: NCT07151378
What this study is testing
What is LECIG (levodopa, carbidopa, entacapone intestinal gel)?
LECIG (levodopa, carbidopa, entacapone intestinal gel) is an investigational medicine, being studied as a potential treatment for parkinson disease (disorder).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures. 2. Able to adhere to the study visit...
- For the purpose of this document, a female is considered of childbearing potential (FCBP), i.e. fertile, following menarche and until becoming...
- Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and...
- In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse...
You likely can't join if
- 1.Women during pregnancy and lactation. 2. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical...
The study team makes the final eligibility decision.
Where it's taking place
- Saarlouis, Saarland, Germany
- Berlin, Germany
- Bottrop, Germany
- Dresden, Germany
- Marburg, Germany
- Tübingen, Germany
- Wolfach, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saarlouis, Saarland, Germany; Berlin, Germany; Bottrop, Germany; Dresden, Germany; Marburg, Germany; Tübingen, Germany and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.