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:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00599196
First received: December 24, 2007
Last updated: August 30, 2011
Last verified: September 2010
Results First Received: December 11, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[units: participants]
  380  
Age [1]
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     215  
>=65 years     165  
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  
[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.



  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


No publications provided by UCB Pharma

Publications automatically indexed to this study:

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00599196     History of Changes
Other Study ID Numbers: SP716, SP513OL
Study First Received: December 24, 2007
Results First Received: December 11, 2009
Last Updated: August 30, 2011
Health Authority: Austria: Agency for Health and Food Safety
Australia: Department of Health and Ageing Therapeutic Goods Administration
Croatia: Ministry of Science, Education and Sports
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Health Research Council
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
South Africa: Department of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic
Italy: Ministry of Health
Spain: Comité Ético de Investigación Clínica
United Kingdom: Medicines and Healthcare Products Regulatory Agency