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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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Missouri
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Genk
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Wilrijk
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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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Toronto
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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/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
Other publications