An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.
SP512OL
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.
2 other identifiers
interventional
217
2 countries
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2002
Longer than P75 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 24, 2007
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
February 25, 2010
CompletedOctober 2, 2014
September 1, 2010
6.4 years
December 24, 2007
November 6, 2009
September 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
7 years
Secondary Outcomes (2)
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.
7 years
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
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)
Study Arms (1)
Rotigotine
EXPERIMENTALRotigotine
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subjects who have completed six months of maintenance treatment in the SP512 double-blind trial
You may not qualify if:
- Subjects who had an ongoing serious adverse event from SP512 double-blind trial that was assessed as related to study medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (42)
Unknown Facility
Peoria, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Englewood, Colorado, United States
Unknown Facility
Danbury, Connecticut, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Pompano Beach, Florida, United States
Unknown Facility
Sunrise, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Fort Wayne, Indiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Southfield, Michigan, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Henderson, Nevada, United States
Unknown Facility
New Brunswick, New Jersey, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
Louisville, New York, United States
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New York, New York, United States
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Asheville, North Carolina, United States
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Durham, North Carolina, United States
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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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Upland, Pennsylvania, United States
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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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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Milwaukee, Wisconsin, United States
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Vernon, British Columbia, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Saskatoon, Saskatchewan, Canada
Related Publications (1)
Elmer LW, Surmann E, Boroojerdi B, Jankovic J. Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: a prospective, open-label extension study. Parkinsonism Relat Disord. 2012 Jun;18(5):488-93. doi: 10.1016/j.parkreldis.2012.01.008. Epub 2012 Feb 10.
PMID: 22326237RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2007
First Posted
January 15, 2008
Study Start
June 1, 2002
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
October 2, 2014
Results First Posted
February 25, 2010
Record last verified: 2010-09