Lecigon reduces hyperdopaminergic neuropsychiatric symptoms
- Trial ID
- NCT07151378
- Official Title
- Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease
- Goal
- Lecigon reduces hyperdopaminergic neuropsychiatric symptoms
- Phase
- PHASE3
- Status
- RECRUITING
- Sponsor
- University Hospital Tuebingen
- Study Type
- INTERVENTIONAL
- Enrollment
- 150 participants
- Conditions
- PARKINSON DISEASE (Disorder)
- Interventions
- LECIG (levodopa, carbidopa, entacapone intestinal gel), Best oral medication
Plain-Language Summary
The goal is to reduce dopaminergic desensitization and the neuropsychiatric complications that can come with long-term intermittent levodopa, like affective fluctuations, impulse control problems, hypomanic or psychotic symptoms, and motor on/off swings. The approach uses LECIG, an intestinal gel combining levodopa, carbidopa and entacapone delivered through a PEG-J tube so levodopa is given continuously; carbidopa prevents peripheral breakdown, entacapone blocks COMT to extend levodopa's effect, and the steady infusion aims to smooth plasma levels and reduce both motor and behavioral swings compared with intermittent oral dosing. Eligible participants are adults 18 to 75 with L-Dopa responsive Parkinson's that began before age 65 and has lasted at least five years, currently taking oral levodopa with motor and affective dopaminergic fluctuations and hyperdopaminergic behaviors, with adequate cognition and retained insight if psychotic symptoms are present, and not already on device assisted therapies.
Locations
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR, Dresden, Germany
- Centre for Neurology, Department forNeurodegenerative Disease, and Hertie-Institute forClinical Brain Research, Tübingen, Germany
- Parkinson-Klinik Ortenau GmbH & Co. KG, Wolfach, Germany
Frequently Asked Questions
- What is this trial testing?
- This trial is studying LECIG (levodopa, carbidopa, entacapone intestinal gel). The goal is to reduce dopaminergic desensitization and the neuropsychiatric complications that can come with long-term intermittent levodopa, like affective fluctuations, impulse control problems, hypomanic or psychotic symptoms, and motor on/off swings. The approach uses LECIG, an intestinal gel combining levodopa, carbidopa and entacapone delivered through a PEG-J tube so levodopa is given continuously; carbidopa prevents peripheral breakdown, entacapone blocks COMT to extend levodopa's effect, and the steady infusion aims to smooth plasma levels and reduce both motor and behavioral swings compared with intermittent oral dosing. Eligible participants are adults 18 to 75 with L-Dopa responsive Parkinson's that began before age 65 and has lasted at least five years, currently taking oral levodopa with motor and affective dopaminergic fluctuations and hyperdopaminergic behaviors, with adequate cognition and retained insight if psychotic symptoms are present, and not already on device assisted therapies.
- Who can participate?
- Participants must be between 18 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 3 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 4 years and 11 months.