An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease
Primary Purpose
Early Stage 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 Early Stage Parkinson's Disease focused on measuring Rotigotine, Neupro®
Eligibility Criteria
Inclusion Criteria:
- Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial
Exclusion Criteria:
- Subjects who had an ongoing serious adverse event from SP513 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
1. Study Identification
Unique Protocol Identification Number
NCT00599196
Brief Title
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 SP513 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
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 early-stage idiopathic Parkinson's disease
Detailed Description
This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 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, 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
381 (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, once daily:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);
Optimal dosing:
During the first year: The maximum Rotigotine dose allowed is 8 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
six 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
six 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 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial
Exclusion Criteria:
Subjects who had an ongoing serious adverse event from SP513 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
Concord
Country
Australia
City
Darlinghurst
Country
Australia
City
East Gosford
Country
Australia
City
Westmead
Country
Australia
City
Innsbruck
Country
Austria
City
Wien
Country
Austria
City
Brussels
Country
Belgium
City
Hoboken
Country
Belgium
City
Zagreb
Country
Croatia
City
Brno
Country
Czech Republic
City
Ostrava
Country
Czech Republic
City
Plzen
Country
Czech Republic
City
Espoo
Country
Finland
City
Kuopio
Country
Finland
City
Lappeenranta
Country
Finland
City
Oulu
Country
Finland
City
Pori
Country
Finland
City
Aix-en -Provence
Country
France
City
Caen Cedex
Country
France
City
Toulouse Cedex
Country
France
City
Aachen
Country
Germany
City
Dresden
Country
Germany
City
Kiel
Country
Germany
City
Marburg
Country
Germany
City
Budapest
Country
Hungary
City
Miskolc
Country
Hungary
City
Pecs
Country
Hungary
City
Hadera
Country
Israel
City
Petach-Tikva
Country
Israel
City
Tel Aviv
Country
Israel
City
Milano
Country
Italy
City
Padova
Country
Italy
City
Pozzilli
Country
Italy
City
Breda
Country
Netherlands
City
Geldrop
Country
Netherlands
City
Auckland
Country
New Zealand
City
Christchurch
Country
New Zealand
City
North Shore
Country
New Zealand
City
Wellington
Country
New Zealand
City
Stavanger
Country
Norway
City
Trondheim
Country
Norway
City
Gdansk
Country
Poland
City
Katowice
Country
Poland
City
Krakόw
Country
Poland
City
Lublin
Country
Poland
City
Mosina k/Poznania
Country
Poland
City
Olsztyn
Country
Poland
City
Warszawa
Country
Poland
City
Cape Town
Country
South Africa
City
Pretoria
Country
South Africa
City
Barcelona
Country
Spain
City
Pamplona
Country
Spain
City
Karlstad
Country
Sweden
City
Stockholm
Country
Sweden
City
Bern
Country
Switzerland
City
Lausanne
Country
Switzerland
City
Birmingham
Country
United Kingdom
City
Blackpool
Country
United Kingdom
City
Glasgow
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
London
Country
United Kingdom
City
Newcastle Upon Tyne
Country
United Kingdom
City
Swansea
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23508526
Citation
Giladi N, Boroojerdi B, Surmann E. The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson's disease. J Neural Transm (Vienna). 2013 Sep;120(9):1321-9. doi: 10.1007/s00702-013-1001-5. Epub 2013 Mar 19.
Results Reference
derived
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
We'll reach out to this number within 24 hrs