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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00332917




Registration number
NCT00332917
Ethics application status
Date submitted
1/06/2006
Date registered
2/06/2006
Date last updated
26/01/2009

Titles & IDs
Public title
An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
Scientific title
An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
Secondary ID [1] 0 0
2006-000858-45
Secondary ID [2] 0 0
S308.3.006
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 S308.3.001 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 S308.3.001

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
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
224
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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Michigan
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Missouri
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Nevada
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New York
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North Carolina
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Rhode Island
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Texas
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Vermont
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Argentina
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Buenos Aires
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Argentina
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Argentina
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Ciudad Autonoma de Buenos Aires
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Ciudad de Buenos Aires
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Argentina
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Sofia
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Barrie
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Calgary
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Greenfield Park
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Markham
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Ottawa
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Quebec
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Saskatoon
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Toronto
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Providencia
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Cali
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Medellin
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Rijeka
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Zagreb
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Tampere
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Wellington South
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Barrios Altos-Lima
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Lima
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Brasov
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Bucuresti
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Craiova
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Belgrade
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Levice
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Nitra
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Durban
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Gauteng
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Pretoria
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Goteborg
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Norrkoping
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Stockholm
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Kharkiv
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Kyiv
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Lviv
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Ukraine
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Vinnitsa

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 S308.3.001 trial
Trial website
https://clinicaltrials.gov/ct2/show/NCT00332917
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/ct2/show/NCT00332917