Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: N 0437; Rotigotine

Criteria

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