An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease (SP715)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rotigotine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Rotigotine, Neupro
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rotigotine
Arm Description
Outcomes
Primary Outcome Measures
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
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
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00594386
Brief Title
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease
Acronym
SP715
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
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Rotigotine, Neupro
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
258 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotigotine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
Description
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.
Description
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame
6 years
Title
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
Country
United States
City
Peoria
State/Province
Arizona
Country
United States
City
Phoenix
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Arizona
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United States
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Tucson
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Arizona
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United States
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Hot Springs
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Arkansas
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United States
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Fountain Valley
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California
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United States
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Fresno
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California
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United States
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Irvine
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California
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United States
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Los Angeles
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California
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United States
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Danbury
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Connecticut
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United States
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Fairfield
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Connecticut
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United States
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New Haven
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Connecticut
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United States
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Miami
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Florida
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United States
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Pompano Beach
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Florida
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United States
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St. Petersburg
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Florida
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United States
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Sunrise
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Florida
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United States
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Atlanta
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Georgia
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United States
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Hoffman Estates
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Illinois
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United States
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Fort Wayne
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Indiana
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United States
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Kansas City
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Kansas
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United States
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Lexington
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Kentucky
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Boston
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Massachusetts
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United States
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Southfield
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Michigan
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United States
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Minneapolis
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Minnesota
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United States
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Henderson
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Nevada
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United States
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Albany
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New York
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United States
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Forest Hills
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New York
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United States
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Louisville
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New York
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United States
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Asheville
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North Carolina
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Raleigh
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North Carolina
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Toledo
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Ohio
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Upland
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Pennsylvania
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Houston
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Texas
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San Antonio
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Texas
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Richmond
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Virginia
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United States
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Roanoke
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Virginia
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Milwaukee
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Wisconsin
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United States
City
Edmonton
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Alberta
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Canada
City
Ottawa
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Ontario
Country
Canada
City
Montrél
State/Province
Quebec
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
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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
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