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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease. (SP512OL)

Primary Purpose

Early-Stage Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rotigotine
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-Stage Parkinson's Disease focused on measuring Rotigotine

Eligibility Criteria

31 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rotigotine

Arm Description

Rotigotine

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

First Posted
December 24, 2007
Last Updated
September 24, 2014
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00594165
Brief Title
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.
Acronym
SP512OL
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

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-Stage Parkinson's Disease
Keywords
Rotigotine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotigotine
Arm Type
Experimental
Arm Description
Rotigotine
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro
Intervention Description
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.
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
7 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
7 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 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)

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 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
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
Peoria
State/Province
Arizona
Country
United States
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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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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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Los Angeles
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California
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Englewood
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Colorado
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Danbury
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Connecticut
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New Haven
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Connecticut
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Miami
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Florida
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Pompano Beach
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Florida
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Sunrise
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Florida
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Atlanta
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Georgia
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Chicago
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Illinois
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Fort Wayne
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Indiana
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New Orleans
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Louisiana
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Boston
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Massachusetts
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Southfield
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Michigan
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Minneapolis
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Minnesota
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St. Louis
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Missouri
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Henderson
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Nevada
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New Brunswick
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New Jersey
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Albany
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New York
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Louisville
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New York
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New York
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New York
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Asheville
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North Carolina
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Durham
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North Carolina
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Cleveland
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Ohio
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Columbus
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Ohio
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Toledo
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Ohio
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Upland
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Pennsylvania
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Dallas
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Houston
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San Antonio
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Richmond
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Virginia
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Roanoke
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Virginia
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Milwaukee
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Wisconsin
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Calgary
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Alberta
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Canada
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Edmonton
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Alberta
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Canada
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Vernon
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British Columbia
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Canada
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Ottawa
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Ontario
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22326237
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.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.

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