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
- Registry Record Last Updated
- 2026-07-13 (this month)
- Estimated Commitment
- Lower commitment estimated from the protocol (based on: 6 study visits). This reflects time and procedures only — confirm details with the study coordinator.
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.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Hoehn and Yahr stage 3 to 5
- Levodopa: Must be taking levodopa (criteria text: "oral treatment with l-dopa and non-ergot dopamine agonist(s) (any preparation, any dosage) 11")
- Motor fluctuations: Must have motor fluctuations (off periods when medication wears off) (criteria text: "presence of dopaminergic motor fluctuations based on patient history 12")
- Deep brain stimulation: Cannot join after DBS surgery (deep brain stimulation) (criteria text: "tremor-dominant pd without dopaminergic response fluctuationt pre-existing device assisted therapy (dat) immediately before study enrolment including with db...")
- Time since diagnosis: Diagnosed at least 5 years ago (criteria text: "disease duration >= 5 years 9")
- Age when symptoms began: Parkinson's must have started before age 65 (criteria text: "age at parkinson's disease onset before 65 years 8")
- Thinking test (MoCA): MoCA memory and thinking score of at least 21 (criteria text: "4. Patients suffering from cognitive impairment (MoCA \< 21) will be excluded for the major reason to obtain valid Ardouin assessments that will be hampered in case cognitive impairment (and therefore insight) is too severe")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people up to age 75.
- This trial does not enroll people who have had (or are scheduled for) DBS surgery.
- This trial requires participants to be taking levodopa.
- This trial requires a Parkinson's diagnosis at least 5 years ago.
- This trial requires motor fluctuations (off periods).
- This trial requires Hoehn and Yahr stage 3 to 5.
- This trial requires a MoCA thinking-test score of at least 21.
Locations
- DRK gemeinnützige Krankenhausgesellschaft mbH Saarland, Saarlouis, Saarland, Germany
- Charité Campus Mitte, Berlin, Germany
- Knappschaft Kliniken Bottrop GmbH, Bottrop, Germany
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR, Dresden, Germany
- University Hospital Marburg, Marburg, Germany
- Centre for Neurology, Department forNeurodegenerative Disease, and Hertie-Institute forClinical Brain Research, Tübingen, Germany
- Parkinson-Klinik Ortenau GmbH & Co. KG, Wolfach, Germany
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07151378. It is the one about "Reduce overactive dopamine related behaviors". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: Study assessments at pre-interventional baseline and at 6-month follow-up (6 months total). Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
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 7 locations.
- Does it cost anything to join?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- 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?
- Study assessments at pre-interventional baseline and at 6-month follow-up (6 months total).