Trials / Recruiting
RecruitingNCT07151378
Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- University Hospital Tuebingen · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LECIG (levodopa, carbidopa, entacapone intestinal gel) | intestinal L-Dopa + entacapone (Lecigon®) |
| DRUG | Best oral medication | Best oral medication |
Timeline
- Start date
- 2025-10-27
- Primary completion
- 2030-09-22
- Completion
- 2030-09-22
- First posted
- 2025-09-03
- Last updated
- 2026-03-12
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT07151378. Inclusion in this directory is not an endorsement.