Smooth motor and behavioral fluctuations
- Trial ID
- NCT07151378
- Official Title
- Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease
- Goal
- Smooth motor and behavioral fluctuations
- 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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.