Thinking and behaviour during intestinal levodopa treatment

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 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