An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.
NCT ID: NCT00594165
Last Updated: 2014-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
217 participants
INTERVENTIONAL
2002-06-30
2008-11-30
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
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.
Interventions
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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 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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Peoria, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fountain Valley, California, United States
Fresno, California, United States
Los Angeles, California, United States
Englewood, Colorado, United States
Danbury, Connecticut, United States
New Haven, Connecticut, United States
Miami, Florida, United States
Pompano Beach, Florida, United States
Sunrise, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Southfield, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Henderson, Nevada, United States
New Brunswick, New Jersey, United States
Albany, New York, United States
Louisville, New York, United States
New York, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Upland, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Milwaukee, Wisconsin, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vernon, British Columbia, Canada
Ottawa, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Countries
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References
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Elmer LW, Surmann E, Boroojerdi B, Jankovic J. Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: a prospective, open-label extension study. Parkinsonism Relat Disord. 2012 Jun;18(5):488-93. doi: 10.1016/j.parkreldis.2012.01.008. Epub 2012 Feb 10.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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SP512OL
Identifier Type: -
Identifier Source: secondary_id
SP0702
Identifier Type: -
Identifier Source: org_study_id
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