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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00501969




Registration number
NCT00501969
Ethics application status
Date submitted
16/07/2007
Date registered
17/07/2007
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 Advanced-Stage Parkinson's Disease
Scientific title
An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa
Secondary ID [1] 0 0
2004-000148-26
Secondary ID [2] 0 0
SP0516
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced 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:

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)
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
Timepoint [1] 0 0
five years
Secondary outcome [1] 0 0
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Timepoint [1] 0 0
five years
Secondary outcome [2] 0 0
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Timepoint [2] 0 0
Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)

Eligibility
Key inclusion criteria
* Subjects who have completed four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial
Minimum age
31 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) double-blind trial that was assessed as related to study medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
395
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bedford Park
Recruitment hospital [2] 0 0
- Concord
Recruitment hospital [3] 0 0
- Darlinghurst
Recruitment hospital [4] 0 0
- East Gosford
Recruitment hospital [5] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- East Gosford
Recruitment postcode(s) [5] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Croatia
State/province [2] 0 0
Zagreb
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Brno
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Ostrava - Poruba
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Pardubice
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Plzen
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha
Country [8] 0 0
Finland
State/province [8] 0 0
Oulu
Country [9] 0 0
Finland
State/province [9] 0 0
Pori
Country [10] 0 0
France
State/province [10] 0 0
Aix-en -Provence
Country [11] 0 0
France
State/province [11] 0 0
Lille cedex
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
Germany
State/province [13] 0 0
Aachen
Country [14] 0 0
Germany
State/province [14] 0 0
Bochum
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Hungary
State/province [16] 0 0
Miskolc
Country [17] 0 0
Hungary
State/province [17] 0 0
Pecs
Country [18] 0 0
Israel
State/province [18] 0 0
Petach-Tikva
Country [19] 0 0
Israel
State/province [19] 0 0
Tel Aviv
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Italy
State/province [21] 0 0
Napoli
Country [22] 0 0
Italy
State/province [22] 0 0
Padova
Country [23] 0 0
Italy
State/province [23] 0 0
Pisa
Country [24] 0 0
Italy
State/province [24] 0 0
Pozzilli
Country [25] 0 0
Italy
State/province [25] 0 0
Roma
Country [26] 0 0
New Zealand
State/province [26] 0 0
Auckland
Country [27] 0 0
New Zealand
State/province [27] 0 0
Christchurch
Country [28] 0 0
New Zealand
State/province [28] 0 0
Wellington
Country [29] 0 0
Norway
State/province [29] 0 0
Bergen
Country [30] 0 0
Norway
State/province [30] 0 0
Stavanger
Country [31] 0 0
Norway
State/province [31] 0 0
Tonsberg
Country [32] 0 0
Norway
State/province [32] 0 0
Trondheim
Country [33] 0 0
Poland
State/province [33] 0 0
Gdansk
Country [34] 0 0
Poland
State/province [34] 0 0
Krakow
Country [35] 0 0
Poland
State/province [35] 0 0
Lublin
Country [36] 0 0
Poland
State/province [36] 0 0
Mosina k/Poznania
Country [37] 0 0
Poland
State/province [37] 0 0
Olsztyn
Country [38] 0 0
Poland
State/province [38] 0 0
Warszawa
Country [39] 0 0
South Africa
State/province [39] 0 0
Cape Town
Country [40] 0 0
South Africa
State/province [40] 0 0
Pretoria
Country [41] 0 0
South Africa
State/province [41] 0 0
Tygerberg
Country [42] 0 0
Spain
State/province [42] 0 0
Barcelona
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Spain
State/province [44] 0 0
San Sebastian
Country [45] 0 0
Sweden
State/province [45] 0 0
Stockholm
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Blackpool
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Glasgow
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Sheffield

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 advanced-stage idiopathic Parkinson's disease
Trial website
https://clinicaltrials.gov/study/NCT00501969
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00501969