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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB BIOSCIENCES GmbH
• Treatments: N 0437; Rotigotine

Criteria

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