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



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:February 2013
End Date:March 2014

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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
We found this trial at
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Charlotte, North Carolina 28207
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Springfield, Massachusetts 01199
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