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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00599196
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : January 18, 2010
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Early Stage Parkinson's Disease Drug: Rotigotine Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2002
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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®


Outcome Measures

Primary Outcome Measures :
  1. Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: six years ]
    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 :
  1. Number of Subjects Who Withdrew From the Trial Due to an Adverse Event [ Time Frame: six years ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  2. 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) ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599196


  Hide Study Locations
Locations
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 Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00599196     History of Changes
Other Study ID Numbers: SP0716
SP513OL ( Other Identifier: UCB )
First Posted: January 23, 2008    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: October 2, 2014
Last Verified: September 2010

Keywords provided by UCB Pharma:
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
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs