A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia.

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

Details

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

Criteria

Inclusion Criteria:

• Subject has idiopathic Parkinson's disease (early- or advanced-stage), as defined by the cardinal sign bradykinesia, plus the presence of at least one of the following: resting tremor, rigidity, or postural instability and is without any other known or suspected cause of Parkinsonism.

• Subject is scheduled for an operation requiring general anesthesia.

Exclusion Criteria:

• Subject has previously been treated with rotigotine.

• Subject has a history of significant skin hypersensitivity to adhesives or other transdermals or recent unresolved contact dermatitis or has a known allergy or hypersensitivity to rotigotine or to other components of the patch.

• Subject is scheduled for a surgical procedure (surgery per protocol(SPP)) that requires magnetic resonance imaging or cardioversion.

• Subject has a high probability to require extended postoperative ventilation (> 24 hours).

• Subject has any medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this trial.