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INITIATE-LECIG: Intestinal levodopa + entacapone therapy (Lecigon®) to counteract dopaminergic desensitization and neuropsychiatric complications in Parkinson’s disease
EU CTIS ID: 2025-521048-39-00
What this study is testing
To show superiority of LECIG therapy compared to best medical treatment on “hyperdopaminergic symptoms” corresponding to Section 1 (items 2 & 4), and section 4 (all items) of the “Ardouin Behavioural Scale” between pre-interventional baseline and 6- month follow-up
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
- Oral treatment with L-Dopa and non-ergot dopamine agonist(s) (any preparation, any dosage); as exception, patients not being treated with dopamine agonists may be enrolled in case they exhibit clinically-relevant impulse control disorder or dopamine-dysregulation syndrome (compulsory and addictive dopamine intake)
- Presence of dopaminergic motor fluctuations based on patient histor
- Preserved dopaminergic motor response of ≥ 30% according to MDS UPDRS III assessed in the practically defined dopaminergic Off and On conditions
- Presence of dopaminergic neuropsychiatric (affective) fluctuations based on patient history
- Presence of behavioural hyperdopaminergic syndrome including clinically relevant neuropsychiatric behavioural abnormalities according Ardouin Behavioural Scale Section 1, hypomanic symptoms, psychosis + Section 4 hyperdopaminergic behaviours (score ≥ 3), eventually further accompanied by impulse control disorders, a/o dopamine dysregulation, syndrome, a/o hallucination – psychosis spectrum; in case symptoms of the hallucination/psychosis or hypomania-mania spectrum are present, retained insight is mandatory at the time of study enrolment
You likely can't join if
- Women during pregnancy and lactation
- Gastrointestinal contraindications against PEG-J tube or T-Port placement
- Tremor-dominant PD without dopaminergic response fluctuations
- Pre-existing device assisted therapy (DAT) immediately before study enrolment including with DBS, LCIG/LECIG, or subcutaneous therapy with apomorphine or foslevodopa; if patient terminated pre-existing subcutaneous therapy, the patient will be eligible after having received oral dopamine replacement therapy for at least 3 months
- Malignancy in a non-remitted stage
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
See the full eligibility criteria
Who can join
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
- Oral treatment with L-Dopa and non-ergot dopamine agonist(s) (any preparation, any dosage); as exception, patients not being treated with dopamine agonists may be enrolled in case they exhibit clinically-relevant impulse control disorder or dopamine-dysregulation syndrome (compulsory and addictive dopamine intake)
- Presence of dopaminergic motor fluctuations based on patient histor
- Preserved dopaminergic motor response of ≥ 30% according to MDS UPDRS III assessed in the practically defined dopaminergic Off and On conditions
- Presence of dopaminergic neuropsychiatric (affective) fluctuations based on patient history
- Presence of behavioural hyperdopaminergic syndrome including clinically relevant neuropsychiatric behavioural abnormalities according Ardouin Behavioural Scale Section 1, hypomanic symptoms, psychosis + Section 4 hyperdopaminergic behaviours (score ≥ 3), eventually further accompanied by impulse control disorders, a/o dopamine dysregulation, syndrome, a/o hallucination – psychosis spectrum; in case symptoms of the hallucination/psychosis or hypomania-mania spectrum are present, retained insight is mandatory at the time of study enrolment
- Able to adhere to the study visit schedule and other protocol requirements.
- Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during the study
- All subjects must agree not to share medication
- Diagnosis of Idiopathic PD, inclusive of familial PD and genetic forms of L-Dopa responsive PD
- Age 18 - 75 years
- Age at Parkinson’s disease onset before 65 years
- Disease duration ≥ 5 years
- Oral medication constant for four weeks prior to baseline visit
What rules you out
- Women during pregnancy and lactation
- Gastrointestinal contraindications against PEG-J tube or T-Port placement
- Tremor-dominant PD without dopaminergic response fluctuations
- Pre-existing device assisted therapy (DAT) immediately before study enrolment including with DBS, LCIG/LECIG, or subcutaneous therapy with apomorphine or foslevodopa; if patient terminated pre-existing subcutaneous therapy, the patient will be eligible after having received oral dopamine replacement therapy for at least 3 months
- Malignancy in a non-remitted stage
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
- History of entacapone-induced diarrhoea under oral entacapone (it is recommended to have tried oral entacapone before entering this study, but this is not mandatory)
- Participation in other clinical trials or observation period of competing trials over the past three months
- 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
- Acute paranoid psychosis without retained insight (however impulse control disorder or dopamine dysregulation syndrome are not an exclusion criterion; illusions or (pseudo)-hallucinations are not an exclusion criterion as long as there is no endangerment of the patients themselves or other persons owing to clinical judgement; patients may be eligible after remission of psychosis/suicidality)
- 7. Severe depression according to ICD-10 criteria; however, affective fluctuations with intermittent depressive symptoms (reversed by dopaminergic medication) are not an exclusion criterion
- Active suicidality without self-distancing (however, suicidal ideation/thoughts or passive wishes of being dead are not an exclusion criterion as long as the patient is credibly distancing from it).
- General contraindications for intestinal L-Dopa therapy (according to Lecigon® Fachinformation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.