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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
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Rotigotine
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Plasma Concentration of Rotigotine After Use. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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
Experimental: 1
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 (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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594464

Locations
Germany
Augsburg, Germany
Bochum, Germany
Bonn, Germany
Bremerhaven, Germany
Dortmund, Germany
Dresden, Germany
Hanau, Germany
Ingolstadt, Germany
Kiel, Germany
Schwerin, Germany
Stralsund, Germany
Ulm, Germany
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site
Product Information  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00594464     History of Changes
Other Study ID Numbers: SP882
Study First Received: December 21, 2007
Results First Received: May 11, 2009
Last Updated: May 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:
Rotigotine
NEUPRO®
Parkinson's Disease (PD)
perioperative use
anaesthesia,

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
 N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013