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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00599196




Registration number
NCT00599196
Ethics application status
Date submitted
24/12/2007
Date registered
23/01/2008
Date last updated
2/10/2014

Titles & IDs
Public title
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease
Scientific 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
Secondary ID [1] 0 0
SP513OL
Secondary ID [2] 0 0
SP0716
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Stage Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rotigotine

Experimental: Rotigotine - Rotigotine


Treatment: Drugs: Rotigotine
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
six years
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
six years
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
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)

Eligibility
Key inclusion criteria
- Subjects who have completed six months of maintenance treatment in the SP513
double-blind trial
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who had an ongoing serious adverse event from SP513 double-blind trial that
was assessed as related to study medication

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- East Gosford
Recruitment hospital [4] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- East Gosford
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Hoboken
Country [5] 0 0
Croatia
State/province [5] 0 0
Zagreb
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Brno
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Ostrava
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Plzen
Country [9] 0 0
Finland
State/province [9] 0 0
Espoo
Country [10] 0 0
Finland
State/province [10] 0 0
Kuopio
Country [11] 0 0
Finland
State/province [11] 0 0
Lappeenranta
Country [12] 0 0
Finland
State/province [12] 0 0
Oulu
Country [13] 0 0
Finland
State/province [13] 0 0
Pori
Country [14] 0 0
France
State/province [14] 0 0
Aix-en -Provence
Country [15] 0 0
France
State/province [15] 0 0
Caen Cedex
Country [16] 0 0
France
State/province [16] 0 0
Toulouse Cedex
Country [17] 0 0
Germany
State/province [17] 0 0
Aachen
Country [18] 0 0
Germany
State/province [18] 0 0
Dresden
Country [19] 0 0
Germany
State/province [19] 0 0
Kiel
Country [20] 0 0
Germany
State/province [20] 0 0
Marburg
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest
Country [22] 0 0
Hungary
State/province [22] 0 0
Miskolc
Country [23] 0 0
Hungary
State/province [23] 0 0
Pecs
Country [24] 0 0
Israel
State/province [24] 0 0
Hadera
Country [25] 0 0
Israel
State/province [25] 0 0
Petach-Tikva
Country [26] 0 0
Israel
State/province [26] 0 0
Tel Aviv
Country [27] 0 0
Italy
State/province [27] 0 0
Milano
Country [28] 0 0
Italy
State/province [28] 0 0
Padova
Country [29] 0 0
Italy
State/province [29] 0 0
Pozzilli
Country [30] 0 0
Netherlands
State/province [30] 0 0
Breda
Country [31] 0 0
Netherlands
State/province [31] 0 0
Geldrop
Country [32] 0 0
New Zealand
State/province [32] 0 0
Auckland
Country [33] 0 0
New Zealand
State/province [33] 0 0
Christchurch
Country [34] 0 0
New Zealand
State/province [34] 0 0
North Shore
Country [35] 0 0
New Zealand
State/province [35] 0 0
Wellington
Country [36] 0 0
Norway
State/province [36] 0 0
Stavanger
Country [37] 0 0
Norway
State/province [37] 0 0
Trondheim
Country [38] 0 0
Poland
State/province [38] 0 0
Gdansk
Country [39] 0 0
Poland
State/province [39] 0 0
Katowice
Country [40] 0 0
Poland
State/province [40] 0 0
Krak?w
Country [41] 0 0
Poland
State/province [41] 0 0
Lublin
Country [42] 0 0
Poland
State/province [42] 0 0
Mosina k/Poznania
Country [43] 0 0
Poland
State/province [43] 0 0
Olsztyn
Country [44] 0 0
Poland
State/province [44] 0 0
Warszawa
Country [45] 0 0
South Africa
State/province [45] 0 0
Cape Town
Country [46] 0 0
South Africa
State/province [46] 0 0
Pretoria
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Pamplona
Country [49] 0 0
Sweden
State/province [49] 0 0
Karlstad
Country [50] 0 0
Sweden
State/province [50] 0 0
Stockholm
Country [51] 0 0
Switzerland
State/province [51] 0 0
Bern
Country [52] 0 0
Switzerland
State/province [52] 0 0
Lausanne
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Birmingham
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Blackpool
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Glasgow
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Liverpool
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Newcastle Upon Tyne
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT00599196
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications