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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson's Disease
Intervention Drug: Rotigotine
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rotigotine
Hide Arm/Group Description Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Period Title: Overall Study
Started 14
Completed 11
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
Delay in operation             2
Arm/Group Title Rotigotine
Hide Arm/Group Description Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  14.3%
>=65 years
12
  85.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
68.7  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
7
  50.0%
Male
7
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 14 participants
14
1.Primary Outcome
Title Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (Subjects having valid data for all three feasibility assessments)
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: Score on scale
5.0  (1.8)
2.Primary Outcome
Title Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (Subjects having valid data for all three feasibility assessments)
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: Score on scale
5.2  (2.2)
3.Primary Outcome
Title Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (Subjects having valid data for all three feasibility assessments)
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: Score on scale
3.9  (1.4)
4.Secondary Outcome
Title Plasma Concentration of Rotigotine After Use.
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set (Subjects for whom a blood sample for determination of the plasma concentration of rotigotine was drawn and a valid determination of the plasma concentration could be done)
Arm/Group Title Rotigotine 2 mg/24h Rotigotine 6mg/24h Rotigotine 8 mg/24h Rotigotine 12 mg/24h Rotigotine 14 mg/24h Rotigotine 16 mg/24h
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1 1 2 2 1 3
Mean (Standard Deviation)
Unit of Measure: ng/ml
0.1640  (0) 0.2480  (0) 0.7570  (0.1569) 0.8405  (0.3302) 0.8689  (0) 1.6958  (2.1951)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rotigotine
Hide Arm/Group Description Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
All-Cause Mortality
Rotigotine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rotigotine
Affected / at Risk (%) # Events
Total   4/14 (28.57%)    
Cardiac disorders   
Ventricular asystole * 1  1/14 (7.14%)  1
Injury, poisoning and procedural complications   
Joint dislocation * 1  1/14 (7.14%)  1
Post procedural haematoma * 1  1/14 (7.14%)  1
Psychiatric disorders   
Hallucination * 1  1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rotigotine
Affected / at Risk (%) # Events
Total   10/14 (71.43%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/14 (7.14%)  1
Ear and labyrinth disorders   
Ear Pain * 1  1/14 (7.14%)  1
Gastrointestinal disorders   
Constipation * 1  3/14 (21.43%)  5
Nausea * 1  3/14 (21.43%)  3
Diarrhoea * 1  1/14 (7.14%)  1
Abdominal pain upper * 1  1/14 (7.14%)  1
Infections and infestations   
Urinary tract infection * 1  3/14 (21.43%)  4
Staphylococcal infection * 1  1/14 (7.14%)  1
Injury, poisoning and procedural complications   
Procedural pain * 1  5/14 (35.71%)  5
Investigations   
Intraocular pressure increased * 1  1/14 (7.14%)  1
Urine uric acid increased * 1  1/14 (7.14%)  1
Metabolism and nutrition disorders   
Iron deficiency * 1  2/14 (14.29%)  2
Hypovolaemia * 1  1/14 (7.14%)  1
Nervous system disorders   
Dysaesthesia * 1  1/14 (7.14%)  1
Paraesthesia * 1  1/14 (7.14%)  1
Balance disorder * 1  1/14 (7.14%)  1
Dementia * 1  1/14 (7.14%)  1
Psychiatric disorders   
Sleep disorder * 1  2/14 (14.29%)  2
Agitation * 1  1/14 (7.14%)  1
Restlessness * 1  1/14 (7.14%)  1
Psychotic disorder * 1  1/14 (7.14%)  2
Skin and subcutaneous tissue disorders   
Pruritus * 1  2/14 (14.29%)  2
Vascular disorders   
Hypotension * 1  1/14 (7.14%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00594464    
Other Study ID Numbers: SP0882
2006-005438-19 ( EudraCT Number )
First Submitted: December 21, 2007
First Posted: January 15, 2008
Results First Submitted: May 11, 2009
Results First Posted: July 3, 2009
Last Update Posted: October 2, 2014