Clinical trial NCT00594165: An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Early-Stage Parkinson's Disease
Keywords: Rotigotine
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 217
Sex: ALL
Minimum age (years): 31
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
timeFrame: 7 years
Secondary outcomes:
measure: Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.
timeFrame: 7 years
measure: Mean Epworth Sleepiness Scale Score During the Open-label Extension.
timeFrame: 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)
Other outcomes:
Locations:
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: Fresno
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Pompano Beach
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Southfield
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: New Brunswick
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Louisville
country: United States
state: New York
city: New York
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Upland
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vernon
country: Canada
state: British Columbia
city: Ottawa
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.