Clinical trial NCT00594386: An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Rotigotine
Neupro
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 258
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 advanced-stage idiopathic Parkinson's Disease.

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.

Eligibility 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

Primary outcomes:
measure: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
timeFrame: 6 years
Secondary outcomes:
measure: Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.
timeFrame: 6 years
measure: Mean Epworth Sleepiness Scale Score During the Open-label Extension.
timeFrame: 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)
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Fountain Valley
country: United States
state: California
city: Fresno
country: United States
state: California
city: Irvine
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Danbury
country: United States
state: Connecticut
city: Fairfield
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: St. Petersburg
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Hoffman Estates
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Southfield
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Henderson
country: United States
state: Nevada
city: Albany
country: United States
state: New York
city: Forest Hills
country: United States
state: New York
city: Louisville
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Upland
country: United States
state: Pennsylvania
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: Edmonton
country: Canada
state: Alberta
city: Ottawa
country: Canada
state: Ontario
city: Montrél
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: