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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/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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Florida
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Illinois
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Kansas
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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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Ohio
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Pennsylvania
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Rhode Island
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Texas
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Ciudad de Buenos Aires
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Cordoba
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Belgium
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Brussels
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Belgium
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Genk
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Belgium
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Wilrijk
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Bulgaria
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Plovdiv
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Sofia
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Canada
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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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Chile
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Providencia
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San Miguel
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Bogota
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Cali
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Medellin
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Rijeka
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Split
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Tampere
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Turku
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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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Yaroslav
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Serbia
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Belgrade
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Serbia
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Nis
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Bratislava
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Levice
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Nitra
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Zilina
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Durban
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Gauteng
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Pretoria
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Goteborg
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Sweden
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Norrkoping
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Stockholm
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Ukraine
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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/ct2/show/NCT00269516
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/NCT00269516