Overview

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.