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Trial record 1 of 1 for:    NCT00594165
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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. (SP512OL)

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ClinicalTrials.gov Identifier: NCT00594165
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : February 25, 2010
Last Update Posted : October 2, 2014
Information provided by (Responsible Party):
UCB Pharma

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-controlled SP512 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease.
Study Start Date : June 2002
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

Arm Intervention/treatment
Experimental: Rotigotine
Drug: Rotigotine

Rotigotine trans-dermal patches:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)

Optimal dosing:

During the first year:

The maximum Rotigotine dose allowed is 6 mg/24 hours.

After the first year: allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.

Other Name: Neupro

Primary Outcome Measures :
  1. Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: 7 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: 7 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 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (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.

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Ages Eligible for Study:   31 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who have completed six months of maintenance treatment in the SP512 double-blind trial

Exclusion Criteria:

  • Subjects who had an ongoing serious adverse event from SP512 double-blind trial that was assessed as related to study medication

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): NCT00594165

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United States, Arizona
Peoria, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
Fountain Valley, California, United States
Fresno, California, United States
Los Angeles, California, United States
United States, Colorado
Englewood, Colorado, United States
United States, Connecticut
Danbury, Connecticut, United States
New Haven, Connecticut, United States
United States, Florida
Miami, Florida, United States
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Sunrise, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
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Chicago, Illinois, United States
United States, Indiana
Fort Wayne, Indiana, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Southfield, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nevada
Henderson, Nevada, United States
United States, New Jersey
New Brunswick, New Jersey, United States
United States, New York
Albany, New York, United States
Louisville, New York, United States
New York, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Durham, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
United States, Pennsylvania
Upland, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Richmond, Virginia, United States
Roanoke, Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, British Columbia
Vernon, British Columbia, Canada
Canada, Ontario
Ottawa, Ontario, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
UCB Pharma
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Additional Information:
Publications of Results:
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00594165    
Other Study ID Numbers: SP0702
First Posted: January 15, 2008    Key Record Dates
Results First Posted: February 25, 2010
Last Update Posted: October 2, 2014
Last Verified: September 2010
Keywords provided by UCB Pharma:
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs