Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy

A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And Mood

This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson´s Disease.

Inclusion Criteria:

• Patients with early or advanced idiopathic Parkinson's Disease
• Patients with advanced idiopathic Parkinson's Disease: intake of Levodopa on a stable dose of at least 200 mg/day
• Unsatisfactory control of Parkinson's Disease motor symptoms under current treatment
• Patients experiencing Apathy associated with Parkinson's Disease
• Hoehn and Yahr stage score of I to IV
• Mini-Mental State Examination score ≥ 25
• If an antidepressant drug is taken, the dose must be stable

Exclusion Criteria:

• Therapy with a Dopamine agonist

• Discontinuation from pervious therapy with a dopamine agonist after an adequate length of treatment, at adequate dose, due to lack of efficacy

• Any medical or psychiatric condition that jeopardizes / compromises patient's ability for participation

• Patient has received Neuroleptics, Dopamine releasing substances, Dopamine modulating substances, Alpha-Methyldopa, Metoclopramide, MAO-A inhibitors, Budipine, or Tolcapone

• Electroconvulsive therapy

• Patient has a

  • current/anticipated psychotherapy or behavior therapy
  • history of deep brain stimulation
  • history of suicide attempt or has suicidal ideation
  • impulse control disorder
  • severe Depression