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An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00505687
First received: July 20, 2007
Last updated: September 24, 2014
Last verified: September 2010
History of Changes
Results First Received: December 8, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Idiopathic Parkinson's Disease
Intervention: Drug: Rotigotine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
An Open-Label Extension Trial to Assess the Safety and Tolerability of Long-term Treatment of Rotigotine in Subjects with Idiopathic Parkinson’s Disease in 26 locations from February 2005 to December 2008.

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 Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Participant Flow:   Overall Study
    Rotigotine
STARTED   186 
COMPLETED   91 
NOT COMPLETED   95 
Important protocol violation                2 
Lack of Efficacy                15 
Adverse Event                48 
Subject withdrew consent                15 
Lost to Follow-up                1 
Other: Underwent Implantation Of DBS                1 
Other: Scheduled DBS Surgery                1 
Other: Prolonged Hospitalization                1 
Other: Patches Would Not Stick D/T Sweat                1 
Other: Neupro Given In Hospital                1 
Other: Disease Progression                1 
Other: As Per Sponsor                8 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rotigotine Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Baseline Measures
   Rotigotine 
Overall Participants Analyzed 
[Units: Participants]
 		 186 
Age 
[Units: Participants]
 		 
<=18 years   0 
Between 18 and 65 years   94 
>=65 years   92 
Age 
[Units: Years]
Mean (Standard Deviation) 		 62.5  (10.4) 
Gender 
[Units: Participants]
 		 
Female   60 
Male   126 
Region of Enrollment 
[Units: Participants]
 		 
United States   80 
Spain   9 
Austria   4 
South Africa   22 
Israel   20 
Germany   22 
United Kingdom   20 
Italy   9 


  Outcome Measures
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1.  Primary:   Number of Subjects With at Least One Adverse Event During This Open-label Extension Study   [ Time Frame: four years ]

Measure Type Primary
Measure Title Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
Measure Description Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame four years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).

Reporting Groups
  Description
Rotigotine Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Measured Values
   Rotigotine 
Participants Analyzed 
[Units: Participants]
 		 186 
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study 
[Units: Subjects]
 		 170 

No statistical analysis provided for Number of Subjects With at Least One Adverse Event During This Open-label Extension Study



2.  Secondary:   Number of Subjects Who Withdrew From the Trial Due to an Adverse Event   [ Time Frame: four years ]

Measure Type Secondary
Measure Title Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Measure Description Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame four years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).

Reporting Groups
  Description
Rotigotine Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Measured Values
   Rotigotine 
Participants Analyzed 
[Units: Participants]
 		 186 
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event 
[Units: Subjects]
 		 48 

No statistical analysis provided for Number of Subjects Who Withdrew From the Trial Due to an Adverse Event



3.  Secondary:   Mean Epworth Sleepiness Scale Score During the Open-label Extension.   [ Time Frame: Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit) ]

Measure Type Secondary
Measure Title Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Measure Description The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.
Time Frame Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.

Reporting Groups
  Description
Rotigotine Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Measured Values
   Rotigotine 
Participants Analyzed 
[Units: Participants]
 		 186 
Mean Epworth Sleepiness Scale Score During the Open-label Extension. 
[Units: Score on a scale]
Mean (Standard Deviation) 		 
Visit 6 (post year 1) (n=164)   9.3  (5.6) 
Visit 10 (post year 2) (n=164)   10.0  (5.9) 
Visit 14 (post year 3) (n=164)   10.3  (6.1) 
End of Treatment (n=182)   10.1  (5.9) 

No statistical analysis provided for Mean Epworth Sleepiness Scale Score During the Open-label Extension.




  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
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  More Information
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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.


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



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00505687     History of Changes
Other Study ID Numbers: SP0833
2004-002641-12 ( EudraCT Number )
Study First Received: July 20, 2007
Results First Received: December 8, 2009
Last Updated: September 24, 2014