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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00599196
First Posted: January 23, 2008
Last Update Posted: October 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
Results First Submitted: December 11, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Early Stage 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 to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Early-Stage Idiopathic Parkinson's Disease from August 2002 to December 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.

Reporting Groups
  Description
Rotigotine Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.

Participant Flow:   Overall Study
    Rotigotine
STARTED   381 
COMPLETED   0 [1] 
NOT COMPLETED   381 
Lack of Efficacy                22 
Adverse Event                93 
Unsatisfactory compliance of subject                3 
Subject withdrew consent                43 
Study ended per sponsor                197 
Lost to Follow-up                17 
Other: Patient Leaving For Israel                1 
Other: Spouse Withdrew Consent                1 
Other: Diagnosis No Longer Idiopathic Pd                1 
Other: Pt Moved To Australia                1 
Other: Patient Stopped Due To Moving                1 
Other: Inv Switched Dopamine Agonist                1 
[1] Study fully recruited. Completed upon market authorization and commercial availability of Neupro.



  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: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.

Baseline Measures
   Rotigotine 
Overall Participants Analyzed 
[Units: Participants]
 380 
Age [1] 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   215 
>=65 years   165 
[1] Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the Safety Set because he withdrew consent prior to receiving any Open Label study medication.
Age 
[Units: Years]
Mean (Standard Deviation)
 61.6  (10.0) 
Gender 
[Units: Participants]
 
Female   150 
Male   230 
Region of Enrollment 
[Units: Participants]
 
Finland   16 
Spain   10 
Austria   12 
Israel   30 
United Kingdom   38 
Italy   9 
Switzerland   4 
France   10 
Czech Republic   44 
Hungary   17 
Poland   65 
Belgium   12 
Croatia   17 
Australia   7 
South Africa   42 
Germany   7 
Norway   4 
Netherlands   5 
New Zealand   19 
Sweden   12 


  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: six years ]

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

3.  Secondary:   Mean Epworth Sleepiness Scale Score During the Open-label Extension   [ Time Frame: Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit) ]


  Serious Adverse Events


  Other Adverse Events


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00599196     History of Changes
Other Study ID Numbers: SP0716
SP513OL ( Other Identifier: UCB )
First Submitted: December 24, 2007
First Posted: January 23, 2008
Results First Submitted: December 11, 2009
Results First Posted: January 18, 2010
Last Update Posted: October 2, 2014