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Trial record 1 of 1 for:    NCT00594464
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A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery (NEUPOS)

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ClinicalTrials.gov Identifier: NCT00594464
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : July 3, 2009
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE January 15, 2008
Results First Submitted Date  ICMJE May 11, 2009
Results First Posted Date  ICMJE July 3, 2009
Last Update Posted Date October 2, 2014
Study Start Date  ICMJE September 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
  • Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist. [ Time Frame: After subject wakes up from general anesthesia ]
    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. [ Time Frame: 2 weeks after surgery ]
    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. [ Time Frame: 2 weeks after surgery ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2008)
Efficacy and safety of rotigotine used during surgery under general anaesthesia assessed by anaesthesiologist after the patient after surgery and wake up of patient and by neurologist and patient. [ Time Frame: Assessment aftersubject wakes up from general anesthesia and 2 weeks after surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2008)
Plasma Concentration of Rotigotine After Use. [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery
Official Title  ICMJE An Explorative, Multicenter, Open-label Pilot Trial With Neupro® (Rotigotine Transdermal Patch) Once Daily Treatment Administered Perioperatively in Patients With Idiopathic Parkinson's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: 1
Rotigotine
Intervention: Drug: Rotigotine
Publications * Wüllner U, Kassubek J, Odin P, Schwarz M, Naumann M, Häck 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2008)
14
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2008)
20
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00594464
Other Study ID Numbers  ICMJE SP0882
2006-005438-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP