- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00594165
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease. (SP512OL)
September 24, 2014 updated by: UCB Pharma
An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease.
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is the open-label extension to the randomized, double-blind, placebo-controlled SP512 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease.
Study Type
Interventional
Enrollment (Actual)
217
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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British Columbia
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Vernon, British Columbia, Canada
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Ontario
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Ottawa, Ontario, Canada
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
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Arizona
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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California
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Fountain Valley, California, United States
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Fresno, California, United States
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Los Angeles, California, United States
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Colorado
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Englewood, Colorado, United States
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Connecticut
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Danbury, Connecticut, United States
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New Haven, Connecticut, United States
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Florida
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Miami, Florida, United States
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Pompano Beach, Florida, United States
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Sunrise, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Illinois
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Chicago, Illinois, United States
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Indiana
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Fort Wayne, Indiana, United States
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Louisiana
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New Orleans, Louisiana, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Southfield, Michigan, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Missouri
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St. Louis, Missouri, United States
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Nevada
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Henderson, Nevada, United States
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New Jersey
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New Brunswick, New Jersey, United States
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New York
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Albany, New York, United States
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Louisville, New York, United States
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New York, New York, United States
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North Carolina
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Asheville, North Carolina, United States
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Durham, North Carolina, United States
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Ohio
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Pennsylvania
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Upland, Pennsylvania, United States
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Texas
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Virginia
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
31 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who have completed six months of maintenance treatment in the SP512 double-blind trial
Exclusion Criteria:
- Subjects who had an ongoing serious adverse event from SP512 double-blind trial that was assessed as related to study medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Rotigotine
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Rotigotine trans-dermal 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: During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours. After the first year: allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
Time Frame: 7 years
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Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
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7 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.
Time Frame: 7 years
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Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
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7 years
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Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Time Frame: Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)
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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.
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Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
December 24, 2007
First Submitted That Met QC Criteria
January 3, 2008
First Posted (Estimate)
January 15, 2008
Study Record Updates
Last Update Posted (Estimate)
October 2, 2014
Last Update Submitted That Met QC Criteria
September 24, 2014
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agonists
- Dopamine Agents
- Rotigotine
Other Study ID Numbers
- SP0702
- SP512OL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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