A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery
Trial end date:
SummaryEvaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia.
Accepts Healthy Volunteers?No
- 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.
- 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
- 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.