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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

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.
 
ClinicalTrials.gov Identifier: NCT00505687
Recruitment Status : Completed
First Posted : July 23, 2007
Results First Posted : January 12, 2010
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief Summary:
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: Rotigotine Phase 3

Detailed Description:
This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease
Study Start Date : February 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rotigotine
Rotigotine
 Drug: Rotigotine

Rotigotine transdermal patches:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)

Optimal dosing:

The maximum rotigotine dose allowed is 16 mg/24 hours.

Other Name: Neupro


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


Secondary Outcome Measures :
  1. Number of Subjects Who Withdrew From the Trial Due to an Adverse Event [ Time Frame: four years ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  2. 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) ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have completed treatment in one of the SP824 (NCT00242008), SP825 (NCT00243971), or SP826 (NCT00243945) trials

Exclusion Criteria:

  • Subjects who had an ongoing serious adverse event from the previous OLE trial that was assessed as related to study medication
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505687


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Florida
St. Petersburg, Florida, United States
United States, Indiana
Fort Wayne, Indiana, United States
United States, Michigan
Southfield, Michigan, United States
United States, New York
Forest Hills, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Raleigh, North Carolina, United States
United States, Texas
Houston, Texas, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Austria
Innsbruck, Austria, 6020
Germany
Bochum, Germany
Dresden, Germany
Kassel, Germany
Ulm, Germany
Israel
Tel Aviv, Israel
Italy
Ancona, Italy
Lucca, Italy
Messina, Italy
South Africa
Pretoria, Gauteng, South Africa
Parow, Western Cape, South Africa
Plumstead, Western Cape, South Africa
Spain
Barcelona, Spain
United Kingdom
Barncose Terrace, Redruth, United Kingdom
Bridgend, United Kingdom
North Shields, United Kingdom
Tyne and Wear, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Additional Information:

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00505687    
Other Study ID Numbers: SP0833
2004-002641-12 ( EudraCT Number )
First Posted: July 23, 2007    Key Record Dates
Results First Posted: January 12, 2010
Last Update Posted: October 2, 2014
Last Verified: September 2010
Keywords provided by UCB Pharma:
Rotigotine
Neupro®
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
 Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs