An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease
An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease
2 other identifiers
interventional
381
19 countries
61
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 P50-P75 for phase_3
Started Aug 2002
Longer than P75 for phase_3
61 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
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 24, 2007
CompletedFirst Posted
Study publicly available on registry
January 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
January 18, 2010
CompletedOctober 2, 2014
September 1, 2010
6.3 years
December 24, 2007
December 11, 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.
six years
Secondary Outcomes (2)
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
six years
Mean Epworth Sleepiness Scale Score During the Open-label Extension
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)
Study Arms (1)
Rotigotine
EXPERIMENTALRotigotine
Interventions
Rotigotine trans-dermal patches, once daily: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours); Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 8 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 SP513 double-blind trial
You may not qualify if:
- Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (63)
Unknown Facility
Concord, Australia
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Darlinghurst, Australia
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East Gosford, Australia
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Westmead, Australia
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Innsbruck, Austria
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Vienna, Austria
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Brussels, Belgium
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Hoboken, Belgium
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Zagreb, Croatia
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Brno, Czechia
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Ostrava, Czechia
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Pilsen, Czechia
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Espoo, Finland
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Kuopio, Finland
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Lappeenranta, Finland
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Oulu, Finland
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Pori, Finland
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Aix-en-Provence, France
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Caen, France
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Toulouse, France
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Aachen, Germany
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Dresden, Germany
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Kiel, Germany
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Marburg, Germany
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Budapest, Hungary
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Miskolc, Hungary
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Pécs, Hungary
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Hadera, Israel
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Petah Tikva, Israel
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Tel Aviv, Israel
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Milan, Italy
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Padua, Italy
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Pozzilli, Italy
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Breda, Netherlands
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Geldrop, Netherlands
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Auckland, New Zealand
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Christchurch, New Zealand
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North Shore, New Zealand
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Wellington, New Zealand
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Stavanger, Norway
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Trondheim, Norway
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Gdansk, Poland
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Katowice, Poland
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Krakόw, Poland
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Lublin, Poland
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Mosina k/Poznania, Poland
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Olsztyn, Poland
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Warsaw, Poland
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Cape Town, South Africa
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Pretoria, South Africa
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Barcelona, Spain
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Pamplona, Spain
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Karlstad, Sweden
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Stockholm, Sweden
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Bern, Switzerland
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Lausanne, Switzerland
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Birmingham, United Kingdom
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Blackpool, United Kingdom
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Glasgow, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Newcastle upon Tyne, United Kingdom
Unknown Facility
Swansea, United Kingdom
Related Publications (1)
Giladi N, Boroojerdi B, Surmann E. The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson's disease. J Neural Transm (Vienna). 2013 Sep;120(9):1321-9. doi: 10.1007/s00702-013-1001-5. Epub 2013 Mar 19.
PMID: 23508526DERIVED
Related Links
MeSH Terms
Interventions
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 23, 2008
Study Start
August 1, 2002
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
October 2, 2014
Results First Posted
January 18, 2010
Record last verified: 2010-09