Levodopa Administration Modalities and Pramipexole in Parkinson's Disease (LAMP-PD study) A multicenter, randomized, four parallel groups, active-controlled, open-label study to evaluate the risk of dyskinesia in early PD.

INTERVENTION: Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa and decarboxylase inhibitor Concentration unit: mg milligram(s) Concentration number: 125‐ Trade Name: COMTAN Pharmaceutical Form: Tablet INN or Proposed INN: Entacapone Concentration unit: mg milligram(s) Concentration number: 200‐ Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa and decarboxylase inhibitor Concentration unit: mg milligram(s) Concentration number: 125‐ Trade Name: STALEVO*100CPR 50/12,5/200MG Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor Concentration unit: mg milligram(s) Concentration number: 262.5‐ Trade Name: STALEVO*100CPR 100/25/200MG Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor Concentration unit: mg milligram(s) Concentration number: 325‐ Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa and decarboxylase inhibitor Concentration unit: mg milligram(s) Concentration number: 275‐ Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa and decarboxylase inhibitor Concentration unit: mg milligram(s) Concentration number: 275‐ Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa and decarboxylase inhibitor Concentration unit: mg milligram(s) Concentration number: 275‐ Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa and decarboxylase inhibitor Concentration unit: mg milligram(s) Concentration number: 275‐ Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa and decarboxylase inhibitor Concentration unit: mg milligram(s) Concentration number: 125‐ Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa and decarboxylase inhibitor Concentration unit: mg milligram(s) Concentration number: 125‐ Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa and decarboxylase inhibitor Concentration unit: mg milligram(s) Concentration number: 125‐ Pharmaceutical Form: Tablet INN or Proposed INN: Levodopa and decarboxylase inhibitor Conce CONDITION: Patients with idiopathic Parkinson's Disease. Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] INCLUSION CRITERIA: 1.Idiopathic PD diagnosed according to the Gelb’s criteria; 2.Aged between 50‐74 years; 3.Hoehn Yahr stage 1‐2.5; 4.Ascertained dopaminergic response; 5.Willing and able to give written informed consent; 6.Willing and able to comply with the study procedures. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range PRIMARY OUTCOME: Main Objective: To evaluate the risk of dyskinesia in early PD patients treated with different modalities of LD administration (CLD, PLD and ILD) or pramipexole over a period of two years (24 months). Primary end point(s): The primary outcome variable is defined as the time until the occurrence of dyskinesia. Dyskinesia will be considered to be present if a patient had a score of 1 or more at Unified Parkinson’s Disease Rating Scale (UPDRS) item 32 during any visit. Dyskinesia will be also assessed by blinded raters at the peak of the drug maximal efficacy by mean of Abnormal Involuntary Movements Scale (AIMS) and Clinical Dyskinesia Rating Scale (CDRS). Dyskinesia will be considered to be present if a patient had a score greater than 0. Secondary Objective: 1.Severity of dyskinesia; 2.Effect of treatments on the parkinsonian disability; 3.Effect of treatments on quality of life; 4.Effect of treatments on the progression of PD; 5.Incidence of wearing off; 6.Time to loss of the LDR; 7.Cumulative daily dosage of LD or Pramipexole needed to maintain an optimal LDR; 8.Percentage of patients requiring supplemental LD; 9.Incidence of adverse events; 10.Incidence of Impulsive Control disorder.