Clinical trial NCT00594464: A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery
Official title: An Explorative, Multicenter, Open-label Pilot Trial With Neupro® (Rotigotine Transdermal Patch) Once Daily Treatment Administered Perioperatively in Patients With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Rotigotine
NEUPRO®
Parkinson's Disease (PD)
perioperative use
anaesthesia,
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.
timeFrame: After subject wakes up from general anesthesia
measure: Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.
timeFrame: 2 weeks after surgery
measure: Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Plasma Concentration of Rotigotine After Use.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Augsburg
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Bremerhaven
country: Germany
city: Dortmund
country: Germany
city: Dresden
country: Germany
city: Hanau
country: Germany
city: Ingolstadt
country: Germany
city: Kiel
country: Germany
city: Schwerin
country: Germany
city: Stralsund
country: Germany
city: Ulm
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Wullner U, Kassubek J, Odin P, Schwarz M, Naumann M, Hack HJ, Boroojerdi B, Reichmann H; NEUPOS Study Group. Transdermal rotigotine for the perioperative management of Parkinson's disease. J Neural Transm (Vienna). 2010 Jul;117(7):855-9. doi: 10.1007/s00702-010-0425-4. Epub 2010 Jun 10.