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

UCB

Status and phase

Completed

Phase 4

Conditions

Parkinson's Disease

Treatments

Drug: Rotigotine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00594464

SP0882

2006-005438-19 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

14 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.