The Rubens Study:

INTERVENTION: Product Name: Pardoprunox Product Code: SLV308 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Pardoprunox hydrochloride CAS Number: 269718‐83‐4 Current Sponsor code: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.1‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Pardoprunox Product Code: SLV308 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Pardoprunox hydrochloride CAS Number: 269718‐83‐4 Current Sponsor code: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.2‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Pardoprunox Product Code: SLV308 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Pardoprunox hydrochloride CAS Number: 269718‐83‐4 Current Sponsor code: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Pardoprunox Product Code: SLV308 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Pardoprunox hydrochloride CAS Number: 269718‐83‐4 Current Sponsor code: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Mirapex Pharmaceutical Form: Tablet INN or Proposed INN: Pramipexole CAS Number: 104632‐26‐0 Current Sponsor code: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate Concentration unit: mg milligram(s) Concentration type: CONDITION: Early Stage Parkinson’s Disease ; MedDRA version: 9.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's PRIMARY OUTCOME: Main Objective: The primary objective is to explore the effective and tolerable dose range of pardoprunox monotherapy in patients with early stage Parkinson’s disease. Primary end point(s): the change from baseline to Week 4/endpoint of the maintenance period of the UPDRS part 3 score of pardoprunox groups compared to placebo; Secondary Objective: The secondary objectives are:; ‐to estimate the minimum effective dose of pardoprunox monotherapy;; ‐to compare the effect size of pardoprunox with pramipexole and placebo for assay sensitivity;; ‐to collect and evaluate data on population‐pharmacokinetics of pardoprunox.; ; The safety objectives are:; ‐to assess the safety and tolerability of different doses of pardoprunox monotherapy in patients with early stage PD;; ‐to determine the optimum titration schedule to the effective doses.; INCLUSION CRITERIA: ‐ The clinical diagnosis of subjects must meet the criteria for "Diagnosis of idiopathic Parkinson’s Disease" according to the modified United Kingdom Parkinson’s Disease Society Brain Bank criteria. ‐ Modified Hoehn and Yahr up to and including stage 3. ‐ Unified Parkinson’s Disease Rating Scale (UPDRS) motor score (part 3) must have a total of at least 10 at baseline ‐ Out patients. ‐ Subjects between the age of = 30 and = 80 years. ‐ For anti‐PD medication other than pardoprunox, the following criteria apply: ‐ subjects may have had treatment with levodopa (L‐dopa) formulations or dopamine agonists up to a total of 90 days; ‐ subjects must have stopped the use of L‐dopa and/or dopamine agonists and amantadine for at least 30 days prior to baseline; ‐ efficacious previous treatment is not allowed to be stopped for the sole purpose of enrolling the subject into this study; ‐ concurrent anti‐PD treatment other than L‐dopa, dop