Back to resultsA Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery (NEUPOS)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Rotigotine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Rotigotine, NEUPRO®, Parkinson's Disease (PD), perioperative use, 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Rotigotine
Outcomes
Primary Outcome Measures
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.
Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Patient did not show unexpected symptoms Item 2: Handling was simple Item 3: Handling wasn't time-consuming Item 4: Patch is a considerable option
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.
Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Switch to patch was easily feasible Item 2: Re-switch was easily feasible Item 3: Patient did not show unexpected symptoms Item 4: Patch is a feasible option
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.
Questionnaire including 3 items Range of sum score: 3 to 18 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Therapy with patch was easily feasible Item 2: Symptoms of Parkinson's Disease were well controlled Item 3: I felt safe with the Parkinson patch
Secondary Outcome Measures
Plasma Concentration of Rotigotine After Use.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00594464
Brief Title
A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery
Acronym
NEUPOS
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
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Rotigotine, NEUPRO®, Parkinson's Disease (PD), perioperative use, anaesthesia,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rotigotine
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.
Description
Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Patient did not show unexpected symptoms Item 2: Handling was simple Item 3: Handling wasn't time-consuming Item 4: Patch is a considerable option
Time Frame
After subject wakes up from general anesthesia
Title
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.
Description
Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Switch to patch was easily feasible Item 2: Re-switch was easily feasible Item 3: Patient did not show unexpected symptoms Item 4: Patch is a feasible option
Time Frame
2 weeks after surgery
Title
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.
Description
Questionnaire including 3 items Range of sum score: 3 to 18 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Therapy with patch was easily feasible Item 2: Symptoms of Parkinson's Disease were well controlled Item 3: I felt safe with the Parkinson patch
Time Frame
2 weeks after surgery
Secondary Outcome Measure Information:
Title
Plasma Concentration of Rotigotine After Use.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
20535621
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.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery
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