An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00599196
First received: December 24, 2007
Last updated: August 30, 2011
Last verified: September 2010
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Early Stage Parkinson's Disease |
Drug: Rotigotine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Rotigotine
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: six years ] [ Designated as safety issue: No ]Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Secondary Outcome Measures:
- Number of Subjects Who Withdrew From the Trial Due to an Adverse Event [ Time Frame: six years ] [ Designated as safety issue: No ]Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
- 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) ] [ Designated as safety issue: No ]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.
| Enrollment: | 381 |
| Study Start Date: | August 2002 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rotigotine
Rotigotine
|
Drug: Rotigotine
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 Name: Neupro®
|
Detailed Description:
This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599196
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Hide Study LocationsLocations
| Australia | |
| Concord, Australia | |
| Darlinghurst, Australia | |
| East Gosford, Australia | |
| Westmead, Australia | |
| Austria | |
| Innsbruck, Austria | |
| Wien, Austria | |
| Belgium | |
| Brussels, Belgium | |
| Hoboken, Belgium | |
| Croatia | |
| Zagreb, Croatia | |
| Czech Republic | |
| Brno, Czech Republic | |
| Ostrava, Czech Republic | |
| Plzen, Czech Republic | |
| Finland | |
| Espoo, Finland | |
| Kuopio, Finland | |
| Lappeenranta, Finland | |
| Oulu, Finland | |
| Pori, Finland | |
| France | |
| Aix-en -Provence, France | |
| Caen Cedex, France | |
| Toulouse Cedex, France | |
| Germany | |
| Aachen, Germany | |
| Dresden, Germany | |
| Kiel, Germany | |
| Marburg, Germany | |
| Hungary | |
| Budapest, Hungary | |
| Miskolc, Hungary | |
| Pecs, Hungary | |
| Israel | |
| Hadera, Israel | |
| Petach-Tikva, Israel | |
| Tel Aviv, Israel | |
| Italy | |
| Milano, Italy | |
| Padova, Italy | |
| Pozzilli, Italy | |
| Netherlands | |
| Breda, Netherlands | |
| Geldrop, Netherlands | |
| New Zealand | |
| Auckland, New Zealand | |
| Christchurch, New Zealand | |
| North Shore, New Zealand | |
| Wellington, New Zealand | |
| Norway | |
| Stavanger, Norway | |
| Trondheim, Norway | |
| Poland | |
| Gdansk, Poland | |
| Katowice, Poland | |
| Krakόw, Poland | |
| Lublin, Poland | |
| Mosina k/Poznania, Poland | |
| Olsztyn, Poland | |
| Warszawa, Poland | |
| South Africa | |
| Cape Town, South Africa | |
| Pretoria, South Africa | |
| Spain | |
| Barcelona, Spain | |
| Pamplona, Spain | |
| Sweden | |
| Karlstad, Sweden | |
| Stockholm, Sweden | |
| Switzerland | |
| Bern, Switzerland | |
| Lausanne, Switzerland | |
| United Kingdom | |
| Birmingham, United Kingdom | |
| Blackpool, United Kingdom | |
| Glasgow, United Kingdom | |
| Liverpool, United Kingdom | |
| London, United Kingdom | |
| Newcastle Upon Tyne, United Kingdom | |
| Swansea, United Kingdom | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00599196 History of Changes |
| Other Study ID Numbers: | SP716, SP513OL |
| Study First Received: | December 24, 2007 |
| Results First Received: | December 11, 2009 |
| Last Updated: | August 30, 2011 |
| Health Authority: | Austria: Agency for Health and Food Safety Australia: Department of Health and Ageing Therapeutic Goods Administration Croatia: Ministry of Science, Education and Sports Belgium: Directorate general for the protection of Public health: Medicines Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Finland: Finnish Medicines Agency Hungary: National Institute of Pharmacy Israel: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) New Zealand: Health Research Council Norway: Norwegian Medicines Agency Poland: Ministry of Health South Africa: Department of Health Sweden: Medical Products Agency Switzerland: Swissmedic Italy: Ministry of Health Spain: Comité Ético de Investigación Clínica United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by UCB, Inc.:
|
Rotigotine Neupro® |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
N 0437 Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013