- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00599196
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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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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Wien, Austria
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Brussels, Belgium
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Hoboken, Belgium
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Zagreb, Croatia
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Brno, Czech Republic
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Ostrava, Czech Republic
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Plzen, Czech Republic
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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 Cedex, France
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Toulouse Cedex, 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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Pecs, Hungary
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Hadera, Israel
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Petach-Tikva, Israel
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Tel Aviv, Israel
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Milano, Italy
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Padova, 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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Warszawa, 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
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Swansea, United Kingdom
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial
Exclusion Criteria:
- Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication
Study Plan
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, 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.
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: six 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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six 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: six 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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six years
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Mean Epworth Sleepiness Scale Score During the Open-label Extension
Time Frame: 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)
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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 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)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
- SP0716
- SP513OL (Other Identifier: UCB)
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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UCB PharmaCompletedEarly-Stage Parkinson's DiseaseUnited States, Canada
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Solvay PharmaceuticalsCompletedEarly Stage Parkinson's DiseaseUnited States, Argentina, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Finland, India, Israel, Mexico, New Zealand, Peru, Romania, Russian Federation, Serbia, Slovakia, South Africa, Sweden, Ukraine
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University Hospital, GrenobleCommissariat A L'energie AtomiqueRecruitingVery Early Stage of Parkinson's DiseaseFrance
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Professor Lu Neurological ClinicUnknownEarly Onset Parkinson DiseaseTaiwan
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