Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain

Completed · Phase 4 · Has a placebo group

Conditions studied: Advanced Idiopathic Parkinson's Disease

In brief

This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain associated with Parkinson's Disease among patients with advanced stages of the disease.

Key facts

Study ID

NCT01744496

Run by

UCB BIOSCIENCES GmbH

People needed

68

Starts

2012-11-01

Expected to finish

2014-01-01

Last updated by the study team

2015-05-01

Who can join

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

You may qualify if…

• Patient has advanced idiopathic Parkinson's Disease associated chronic pain assessed by a Likert Pain Scale
• Patient is taking Levodopa with a stable daily dose of at least 200 mg for at least 21 days prior to start
• Hoehn and Yahr stage score of II to IV
• Mini-Mental State Examination (MMSE) score ≥ 25
• If an antidepressant drug is taken, the dose must be stable for at least 21 days

You may not qualify if…

• Therapy with a Dopamine Agonist within 21 days prior to start
• Discontinuation from previous Dopamine Agonist Therapy due to lack of efficacy
• Therapy with Dopamine-modulating substances 21 days prior to start
• Therapy with analgesics for the treatment for pain, unless the dose has been stable
• Chronic alcohol or drug abuse
• Medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study
• Hypersensitivity to any components of the Investigational Medicinal Product (IMP) or comparative drugs
• Atypical Parkinson's Disease Syndrome due to drugs
• History of deep brain stimulation
• Significant skin disease that would make transdermal drug use inappropriate
• Electroconvulsive therapy within 12 weeks prior to start
• Evidence of an Impulse Control Disorder
• Previous diagnosis of severe Restless Legs Syndrome
• Chronic Migraine
• Severe Depression
• Symptomatic Orthostatic Hypotension

Where it is running

• 2113 — Gilbert, Arizona, United States
• 2120 — Sunnyvale, California, United States
• 2109 — Tampa, Florida, United States
• 2107 — Chicago, Illinois, United States
• 2102 — Lexington, Kentucky, United States
• 2118 — Advance, North Carolina, United States
• 2117 — Cincinnati, Ohio, United States
• 2103 — Tulsa, Oklahoma, United States
• 2101 — Roanoke, Virginia, United States
• 2104 — Milwaukee, Wisconsin, United States
• 1204 — Gera, Germany
• 1607 — Gdansk, Poland
• 1603 — Krakow, Poland
• 1609 — Olsztyn, Poland
• 1804 — Bratislava, Slovakia
• 1805 — Dubnica nad Váhom, Slovakia

Full record on ClinicalTrials.gov

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