LECIG for Parkinson's (NCT07151378)
Reduce overactive dopamine related behaviors
- Trial ID
- NCT07151378
- Official Title
- Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease
- Goal
- Reduce overactive dopamine related behaviors
- 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 study aims to reduce loss of response to dopamine treatment and the related mood and behavior problems that can come with it, by seeing if intestinal treatment improves those symptoms more than the best oral medicines. It tests Lecig, an intestinal gel that delivers levodopa together with carbidopa and entacapone directly into the intestine, compared with best oral medication, and will compare symptoms from before treatment to six months after using the Ardouin Behavioural Scale. The main focus is on overactive dopamine-related behaviors, such as impulsive actions, hypomanic signs, or psychotic-type symptoms. Adults 18 to 75 years old with Parkinson’s that began before age 65, at least five years’ duration, on levodopa with motor and mood/behavior fluctuations, are the people being sought, while those with severe cognitive impairment, active psychosis without insight, or medical contraindications to intestinal therapy are excluded.
Locations
- DRK gemeinnützige Krankenhausgesellschaft mbH Saarland, Saarlouis, Saarland, Germany
- 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 study aims to reduce loss of response to dopamine treatment and the related mood and behavior problems that can come with it, by seeing if intestinal treatment improves those symptoms more than the best oral medicines. It tests Lecig, an intestinal gel that delivers levodopa together with carbidopa and entacapone directly into the intestine, compared with best oral medication, and will compare symptoms from before treatment to six months after using the Ardouin Behavioural Scale. The main focus is on overactive dopamine-related behaviors, such as impulsive actions, hypomanic signs, or psychotic-type symptoms. Adults 18 to 75 years old with Parkinson’s that began before age 65, at least five years’ duration, on levodopa with motor and mood/behavior fluctuations, are the people being sought, while those with severe cognitive impairment, active psychosis without insight, or medical contraindications to intestinal therapy are excluded.
- Who can participate?
- Participants must be between 18 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 4 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.
- 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.
- 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.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- There is a pre-interventional baseline visit and a 6-month follow-up visit.