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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00335374




Registration number
NCT00335374
Ethics application status
Date submitted
8/06/2006
Date registered
9/06/2006
Date last updated
6/02/2009

Titles & IDs
Public title
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
Scientific title
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
Secondary ID [1] 0 0
2006-000859-18
Secondary ID [2] 0 0
S308.3.008
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 - Pardoprunox

Experimental: 1 -


Treatment: Drugs: Pardoprunox
12 -42 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: laboratory data, adverse events, vital signs, ECG
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline
Timepoint [1] 0 0
24 weeks

Eligibility
Key inclusion criteria
* Patients who have completed S308.3.003 trial
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.003

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
303 - Bedford Park
Recruitment hospital [2] 0 0
304 - Cheltenham
Recruitment hospital [3] 0 0
301 - Concord
Recruitment hospital [4] 0 0
Site 300 - East Gosford
Recruitment hospital [5] 0 0
302 - Westmead
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Cheltenham
Recruitment postcode(s) [3] 0 0
- Concord
Recruitment postcode(s) [4] 0 0
- East Gosford
Recruitment postcode(s) [5] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
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United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
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Czech Republic
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Kralove
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Olomouc
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Ostrava
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Pardubice
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Plzen
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Estonia
State/province [17] 0 0
Tallinn
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Estonia
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Tartu
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Germany
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Bochum
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Germany
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Gottingen
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Lubeck
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Germany
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Wiesbaden
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India
State/province [25] 0 0
Bangalore
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India
State/province [26] 0 0
Hyderabaad
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India
State/province [27] 0 0
Kerala
Country [28] 0 0
India
State/province [28] 0 0
Mumbai
Country [29] 0 0
Italy
State/province [29] 0 0
Grosseto
Country [30] 0 0
Italy
State/province [30] 0 0
Lido di Camaiore
Country [31] 0 0
Italy
State/province [31] 0 0
Pescara
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Lithuania
State/province [33] 0 0
Kaunas
Country [34] 0 0
Lithuania
State/province [34] 0 0
Vilnius
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Malaysia
State/province [35] 0 0
Kelantan
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Malaysia
State/province [36] 0 0
Kuala Lumpur
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Malaysia
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Pulau Pinang
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Netherlands
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Eindhoven
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Netherlands
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Groningen
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Netherlands
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Hertogenbosch
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Poland
State/province [41] 0 0
Gdansk
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Poland
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Kalisz
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Poland
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Katowice
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Poland
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Krakow
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Poland
State/province [45] 0 0
Leszno
Country [46] 0 0
Poland
State/province [46] 0 0
Lublin
Country [47] 0 0
Poland
State/province [47] 0 0
Mosina
Country [48] 0 0
Portugal
State/province [48] 0 0
Coimbra
Country [49] 0 0
Portugal
State/province [49] 0 0
Lisboa
Country [50] 0 0
South Africa
State/province [50] 0 0
Cape Town
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South Africa
State/province [51] 0 0
Gauteng
Country [52] 0 0
South Africa
State/province [52] 0 0
Pretoria
Country [53] 0 0
South Africa
State/province [53] 0 0
Sandton
Country [54] 0 0
Taiwan
State/province [54] 0 0
Hualien
Country [55] 0 0
Taiwan
State/province [55] 0 0
Kaohsiung Hsien
Country [56] 0 0
Taiwan
State/province [56] 0 0
Kaohsiung
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Taiwan
State/province [57] 0 0
Kwei-Shan
Country [58] 0 0
Taiwan
State/province [58] 0 0
Taipei
Country [59] 0 0
Thailand
State/province [59] 0 0
Bangkok
Country [60] 0 0
Thailand
State/province [60] 0 0
Ubonratchathani

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Solvay Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.003 trial
Trial website
https://clinicaltrials.gov/study/NCT00335374
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Director Solvay
Address 0 0
Solvay Pharmaceuticals
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/NCT00335374