An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease
An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa
2 other identifiers
interventional
395
16 countries
52
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 advanced-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 2004
Typical duration for phase_3
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 16, 2007
CompletedFirst Posted
Study publicly available on registry
July 17, 2007
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 12, 2010
CompletedOctober 2, 2014
March 1, 2012
4.3 years
July 16, 2007
December 8, 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.
five years
Secondary Outcomes (2)
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
five years
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)
Study Arms (1)
Rotigotine
EXPERIMENTALRotigotine
Interventions
Rotigotine trans-dermal patches once daily: 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)
Eligibility Criteria
You may qualify if:
- Subjects who have completed four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial
You may not qualify if:
- Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) double-blind trial that was assessed as related to study medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (53)
Unknown Facility
Bedford Park, Australia
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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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Zagreb, Croatia
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Brno, Czechia
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Ostrava - Poruba, Czechia
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Pardubice, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Oulu, Finland
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Pori, Finland
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Aix-en-Provence, France
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Lille, France
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Lyon, France
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Aachen, Germany
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Bochum, Germany
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Budapest, Hungary
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Miskolc, Hungary
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Pécs, Hungary
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Petah Tikva, Israel
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Tel Aviv, Israel
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Milan, Italy
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Napoli, Italy
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Padua, Italy
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Pisa, Italy
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Pozzilli, Italy
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Roma, Italy
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Auckland, New Zealand
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Christchurch, New Zealand
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Wellington, New Zealand
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Bergen, Norway
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Stavanger, Norway
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Trondheim, Norway
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Tønsberg, Norway
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Gdansk, Poland
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Krakow, 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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Tygerberg, South Africa
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Barcelona, Spain
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Donostia / San Sebastian, Spain
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Madrid, Spain
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Stockholm, Sweden
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Blackpool, United Kingdom
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Glasgow, United Kingdom
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Sheffield, United Kingdom
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
July 16, 2007
First Posted
July 17, 2007
Study Start
August 1, 2004
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
October 2, 2014
Results First Posted
January 12, 2010
Record last verified: 2012-03