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

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

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.

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

Details

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

Criteria

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

• 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