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Trial record 1 of 1 for:    NCT00594386
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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease (SP715)

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ClinicalTrials.gov Identifier: NCT00594386
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : December 18, 2009
Last Update Posted : October 2, 2014
Sponsor:
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 advanced-stage idiopathic Parkinson's Disease.

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

Detailed Description:
This is the open-label extension to the randomized, double-blind, placebo-controlled SP650 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease who are not well-controlled on Levodopa.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease.
Study Start Date : August 2002
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

Arm Intervention/treatment
Experimental: Rotigotine Drug: Rotigotine

Rotigotine transdermal 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: 6 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: 6 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 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (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
Criteria

Inclusion Criteria:

  • Subjects who have completed six months of maintenance treatment in the SP650 double-blind trial

Exclusion Criteria:

  • Subjects who had an ongoing serious adverse event from the SP650 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): NCT00594386


Locations
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United States, Alabama
Huntsville, Alabama, United States
United States, Arizona
Peoria, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
Fountain Valley, California, United States
Fresno, California, United States
Irvine, California, United States
Los Angeles, California, United States
United States, Connecticut
Danbury, Connecticut, United States
Fairfield, Connecticut, United States
New Haven, Connecticut, United States
United States, Florida
Miami, Florida, United States
Pompano Beach, Florida, United States
St. Petersburg, Florida, United States
Sunrise, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Hoffman Estates, Illinois, United States
United States, Indiana
Fort Wayne, Indiana, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Kentucky
Lexington, Kentucky, 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, Nevada
Henderson, Nevada, United States
United States, New York
Albany, New York, United States
Forest Hills, New York, United States
Louisville, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Raleigh, North Carolina, United States
United States, Ohio
Toledo, Ohio, United States
United States, Pennsylvania
Upland, Pennsylvania, United States
United States, Texas
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
Edmonton, Alberta, Canada
Canada, Ontario
Ottawa, Ontario, Canada
Canada, Quebec
Montrél, Quebec, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Additional Information:
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00594386    
Other Study ID Numbers: SP0715
First Posted: January 15, 2008    Key Record Dates
Results First Posted: December 18, 2009
Last Update Posted: October 2, 2014
Last Verified: September 2010
Keywords provided by UCB Pharma:
Rotigotine
Neupro
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
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs