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Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain

NCT01744496•UCB BIOSCIENCES GmbH

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+6 more criteria

Locations (16)

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

Key Dates

Start Date

November 1, 2012

Primary Completion Date

December 1, 2013

Completion Date

January 1, 2014

Last Updated

May 1, 2015

Enrollment

ACTUAL participants

Conditions

Advanced Idiopathic Parkinson's Disease

Interventions

Rotigotine

DRUG

Placebo

DRUG