Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study)

Exclusion Criteria

• •1. Non-idiopathic PD (for example, atypical parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, Parkinson-plus syndrome).
• •2. Signs of motor complications with a total score of MDS-UPDRS Part IV A+B+C greater than '0' (zero).
• •3. Treatment with prohibited medication: COMT inhibitors (eg, entacapone, tolcapone), antiemetics with antidopaminergic action (except domperidone) or Duopa™ (carbidopa/levodopa intestinal gel) within the 4 weeks before screening.
• •4. Concomitant use of monoamine oxidase (MAO-A and MAO-B) inhibitors (eg, phenelzine, tranylcypromine and moclobemide) other than those for the treatment of PD.
• •5. Previous or planned (during the entire study duration) deep brain stimulation.
• •6. Previous stereotactic surgery (eg, pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period.
• •7. Any investigational medicinal product within the 3 months (or within 5 half-lives, whichever is longer) before screening.
• •8. Any medical condition that might place the subject at increased risk or interfere with study assessments.
• •9. Past (within the past year) or present history of suicidal ideation or suicide attempts, as determined by a positive response ('Yes') to either Question 4 or Question 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) (Screening questions)
• •10. Current or previous (within the past year) diagnosis of psychosis, severe major depression, or other psychiatric disorders that, based on the Investigator's judgment, might place the subject at increased risk or interfere with assessments.
• •11. A clinically relevant electrocardiogram (ECG) abnormality (relevance should be assessed by a cardiologist if needed).
• •12. Current evidence of unstable cardiovascular disease, including but not limited to uncontrolled hypertension, myocardial infarction with important systolic or diastolic dysfunction, unstable angina, congestive heart failure (New York Heart Association Class ≥III), and significant cardiac arrhythmia (Mobitz II 2nd or 3rd degree AV block or any other arrhythmia causing hemodynamic repercussions as symptomatic bradycardia or syncope).
• •13. Prior renal transplant or current renal dialysis.
• •14. Pheochromocytoma, paraganglioma or other catecholamine secretive neoplasm.
• •15. Known hypersensitivity to any ingredients of the study treatment.
• •16. History of neuroleptic malignant syndrome (NMS) or NMS-like syndromes, or non-traumatic rhabdomyolysis.
• •17. Malignancy within the past 5 years (eg, melanoma, prostate cancer), excluding cutaneous basal or squamous cell cancer resolved by excision.
• •18. Unstable active narrow-angle or unstable wide-angle glaucoma.
• •19. History of or current evidence of any relevant disease in the context of this study, ie, with respect to the safety of the subject or related to the study conditions, eg, which may influence the absorption or metabolism (such as a relevant liver disease) of the study treatment.
• •20. Any abnormality in the liver enzymes (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) \>2 times the upper limit of the normal range, in the screening laboratory tests results.
• •21. Plasma sodium less than 130 mmol/L, white blood cell count less than 3000 cells/mm3, or any other relevant clinical laboratory abnormality that, in the Investigator's opinion, may compromise the subject's safety.
• •22. Positive SARS-CoV-2 test at screening.
• •23. Evidence of an ICD (one or more positive modules on the mMIDI)