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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00269516




Registration number
NCT00269516
Ethics application status
Date submitted
22/12/2005
Date registered
23/12/2005
Date last updated
29/08/2008

Titles & IDs
Public title
SLV308 for Treatment of Patients With Early Parkinson's Disease
Scientific title
A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease
Secondary ID [1] 0 0
S308.3.001
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
Treatment: Drugs - Pardoprunox
Treatment: Drugs - Pardoprunox
Treatment: Drugs - Placebo

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -

Placebo comparator: 4 -


Treatment: Drugs: pardoprunox
fixed dose 6 mg

Treatment: Drugs: Pardoprunox
fixed dose 12 mg

Treatment: Drugs: Pardoprunox
12-42mg

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

Outcomes
Primary outcome [1] 0 0
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* Diagnosis of idiopathic Parkinson's Disease,
* Early stage of disease, Modified Hoehn & Yahr up to stage III,
* UPDRS motor score (part III) 10 at baseline.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
* Patients who have undergone surgery for the treatment of PD,
* Presence of dyskinesias,
* Motor fluctuations or loss of postural reflexes,
* Clinically significant abnormalities,
* Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
* Antipsychotic.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
468
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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California
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Illinois
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Michigan
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Wilrijk
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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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Quebec
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Saskatoon
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Toronto
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Providencia
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Bucuresti
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Nis
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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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Vinnytsya

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.
Trial website
https://clinicaltrials.gov/study/NCT00269516
Trial related presentations / publications
Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3.
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/NCT00269516