An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease
NCT ID: NCT00594386
Last Updated: 2014-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
258 participants
INTERVENTIONAL
2002-08-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rotigotine
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
31 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Huntsville, Alabama, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Fountain Valley, California, United States
Fresno, California, United States
Irvine, California, United States
Los Angeles, California, United States
Danbury, Connecticut, United States
Fairfield, Connecticut, United States
New Haven, Connecticut, United States
Miami, Florida, United States
Pompano Beach, Florida, United States
St. Petersburg, Florida, United States
Sunrise, Florida, United States
Atlanta, Georgia, United States
Hoffman Estates, Illinois, United States
Fort Wayne, Indiana, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Boston, Massachusetts, United States
Southfield, Michigan, United States
Minneapolis, Minnesota, United States
Henderson, Nevada, United States
Albany, New York, United States
Forest Hills, New York, United States
Louisville, New York, United States
Asheville, North Carolina, United States
Raleigh, North Carolina, United States
Toledo, Ohio, United States
Upland, Pennsylvania, United States
Houston, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Milwaukee, Wisconsin, United States
Edmonton, Alberta, Canada
Ottawa, Ontario, Canada
Montrél, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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SP0715
Identifier Type: -
Identifier Source: org_study_id
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