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

Completed · Phase 4 · Has a placebo group

Conditions studied: Idiopathic Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT01782222

Run by

UCB BIOSCIENCES GmbH

People needed

122

Starts

2013-02-01

Expected to finish

2014-03-01

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 4320 — Birmingham, Alabama, United States
• 4309 — Oxnard, California, United States
• 4306 — Ormond Beach, Florida, United States
• 4311 — Palm Beach Gardens, Florida, United States
• 4313 — Tampa, Florida, United States
• 4314 — Decatur, Georgia, United States
• 4318 — Chicago, Illinois, United States
• 4316 — Winfield, Illinois, United States
• 4322 — Des Moines, Iowa, United States
• 4304 — Kansas City, Kansas, United States
• 4326 — Springfield, Massachusetts, United States
• 4330 — Ocean Springs, Mississippi, United States
• 4302 — Las Vegas, Nevada, United States
• 4303 — Commack, New York, United States
• 4317 — New York, New York, United States
• 4323 — New York, New York, United States
• 4319 — Asheville, North Carolina, United States
• 4325 — Charlotte, North Carolina, United States
• 4329 — Akron, Ohio, United States
• 4312 — Cincinnati, Ohio, United States
• 4324 — Beaufort, South Carolina, United States
• 4332 — Charleston, South Carolina, United States
• 4305 — San Antonio, Texas, United States
• 4307 — Salt Lake City, Utah, United States
• 4333 — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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