Trial Information

Summary: Trial to Assess PD Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 5-Arm, Parallel-Group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-Stage Parkinson's Disease

The purpose of this study is to show rotigotine dose response at four doses of rotigotine used with L-dopa in treating advanced stage Parkinson's disease

Inclusion Criteria:

• PD greater than 3 years
• Stable dose L-dopa but symptoms not adequately controlled and have "off" time.
• Able and willing to complete diary on specific days.

Exclusion Criteria:

• Previous use of rotigotine or Neupro
• Atypical Parkinson's syndrome
• Pallidotomy
• Thalamotomy
• Deep brain stimulation
• Fetal tissue transplant
• Dementia
• Psychosis
• Hallucinations
• Epilepsy
• Renal or hepatic dysfunction
• Clinically relevant cardiac dysfunction
• Symptomatic orthostatic hypotension
• Skin sensitivity to adhesives or unresolved contact dermatitis
• History of chronic alcohol or drug abuse
• Pregnant or of child-bearing potential
• Impulse control disorder.

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Trial listings updated: June 1, 2008 at 6:43:27 AM