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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00594464
First received: December 21, 2007
Last updated: May 25, 2012
Last verified: December 2010
History of Changes

December 21, 2007
May 25, 2012
September 2007
May 2008   (final data collection date for primary outcome measure)
  • Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist. [ Time Frame: After subject wakes up from general anesthesia ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
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 ]
Complete list of historical versions of study NCT00594464 on ClinicalTrials.gov Archive Site
Plasma Concentration of Rotigotine After Use. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Plasma concentration of rotigotine after use. [ Time Frame: 24 hours ]
Not Provided
Not Provided
 
A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery
An Explorative, Multicenter, Open-label Pilot Trial With Neupro® (Rotigotine Transdermal Patch) Once Daily Treatment Administered Perioperatively in Patients With Idiopathic Parkinson's Disease

Evaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
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.
Experimental: 1
Rotigotine
Intervention: Drug: Rotigotine
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. 2010 Jul;117(7):855-9. Epub 2010 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00594464
SP882
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
December 2010

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