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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00594464

Purpose

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

Condition	Intervention	Phase
Parkinson's Disease	Drug: Rotigotine	Phase IV

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Anesthesia Parkinson's Disease

Drug Information available for: Rotigotine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by UCB:

Primary Outcome Measures:

Efficacy and safety of rotigotine used during surgery under general anaesthesia assessed by anaesthesiologist after surgery and wake up of patient and assessed by neurologist and patient. [ Time Frame: Assessment after subject wakes up from general anesthesia and 2 weeks after surgery ]

Secondary Outcome Measures:

Plasma concentration of rotigotine after use. [ Time Frame: 24 hours ]

Enrollment:	14
Study Start Date:	September 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rotigotine	Drug: Rotigotine 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h patch; Single patches and a combination of 2 of these patches for a dosage of up to 16 mg/24 h; One (1) regimen on day of surgery, but exceptionally extended for up to 2 (two) weeks if the patient requires unexpected ventilation after surgery.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 (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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594464

Locations

Germany

Dresden, Germany

Bonn, Germany

Hanau, Germany

Kiel, Germany

Ulm, Germany

Bochum, Germany

Stralsund, Germany

Ingolstadt, Germany

Bremerhaven, Germany

Dortmund, Germany

Schwerin, Germany

Augsburg, Germany

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP882
Study First Received:	December 21, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00594464
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB:

Rotigotine
NEUPRO®
Parkinson's Disease

PD
perioperative use
anaesthesia,

Study placed in the following topic categories:

Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
N 0437

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases

Dopamine Agents
Dopamine Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009