Text Size

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
Results First Received: May 11, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Parkinson's Disease
Intervention: Drug: Rotigotine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rotigotine Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.

Participant Flow:   Overall Study
    Rotigotine  
STARTED     14  
COMPLETED     11  
NOT COMPLETED     3  
Withdrawal by Subject                 1  
Delay in operation                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Rotigotine Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.

Baseline Measures
    Rotigotine  
Number of Participants  
[units: participants]
 		  14  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     12  
Age  
[units: years]
Mean ± Standard Deviation 		  68.7  ± 5.9  
Gender  
[units: participants]
 		 
Female     7  
Male     7  
Region of Enrollment  
[units: participants]
 		 
Germany     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.   [ Time Frame: After subject wakes up from general anesthesia ]
  Show Outcome Measure 1

2.  Primary:   Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.   [ Time Frame: 2 weeks after surgery ]
  Show Outcome Measure 2

3.  Primary:   Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.   [ Time Frame: 2 weeks after surgery ]
  Show Outcome Measure 3

4.  Secondary:   Plasma Concentration of Rotigotine After Use.   [ Time Frame: 24 hours ]
  Show Outcome Measure 4


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Rotigotine Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.

Other Adverse Events
    Rotigotine  
Total, other (not including serious) adverse events    
# participants affected / at risk     10/14  
Blood and lymphatic system disorders    
Anaemia * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Ear and labyrinth disorders    
Ear Pain * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Gastrointestinal disorders    
Constipation * 1  
# participants affected / at risk     3/14 (21.43%)  
# events     5  
Nausea * 1  
# participants affected / at risk     3/14 (21.43%)  
# events     3  
Diarrhoea * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Abdominal pain upper * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Infections and infestations    
Urinary tract infection * 1  
# participants affected / at risk     3/14 (21.43%)  
# events     4  
Staphylococcal infection * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Injury, poisoning and procedural complications    
Procedural pain * 1  
# participants affected / at risk     5/14 (35.71%)  
# events     5  
Investigations    
Intraocular pressure increased * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Urine uric acid increased * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Metabolism and nutrition disorders    
Iron deficiency * 1  
# participants affected / at risk     2/14 (14.29%)  
# events     2  
Hypovolaemia * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Nervous system disorders    
Dysaesthesia * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Paraesthesia * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Balance disorder * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Dementia * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Psychiatric disorders    
Sleep disorder * 1  
# participants affected / at risk     2/14 (14.29%)  
# events     2  
Agitation * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Restlessness * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     1  
Psychotic disorder * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     2  
Skin and subcutaneous tissue disorders    
Pruritus * 1  
# participants affected / at risk     2/14 (14.29%)  
# events     2  
Vascular disorders    
Hypotension * 1  
# participants affected / at risk     1/14 (7.14%)  
# events     3  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 9.1



  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: +1 877 822 9493


Publications of Results:


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