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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/NCT00335166




Registration number
NCT00335166
Ethics application status
Date submitted
8/06/2006
Date registered
9/06/2006
Date last updated
3/04/2008

Titles & IDs
Public title
SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
Scientific title
A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled 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
Not requested yet
Secondary ID [2] 0 0
S308.3.003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Stage Parkinson 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 - Pardaprunox
Treatment: Drugs - pramipexole
Treatment: Drugs - Placebo Comparator

Experimental: 1 -

Active Comparator: 2 -

Placebo Comparator: 3 -


Treatment: Drugs: Pardaprunox
12-42 mg

Treatment: Drugs: pramipexole
1.5-4.5 mg

Treatment: Drugs: Placebo Comparator
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
24 weeks
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
24 weeks

Eligibility
Key inclusion criteria
- Diagnosis of idiopathic Parkinson's Disease, Modified Hoehn & Yahr up to stage III,
UPDRS motor score (part III) must have a total of at least 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,

- Current presence of dyskinesias,

- Motor fluctuations or loss of postural reflexes,

- A history of non-response to an adequate course of l-dopa or a dopamine agonist,

- Patients for whom previously treatment with dopamine agonists needed to terminate
because of induction of psychosis (i.e. hallucinations) and /or sleep attacks.

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
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
330
Accrual to date
Final
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
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
- 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
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Michigan
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Minnesota
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New York
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United States of America
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North Carolina
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Czech Republic
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Kralove
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Czech Republic
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Olomouc
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Czech Republic
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Ostrava
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Czech Republic
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Pardubice
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Czech Republic
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Plzen
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Aix en Provence
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France
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Toulon
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France
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Toulouse
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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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Homburg
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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
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Bangalore
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India
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Hyderabad
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India
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Kerala
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India
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Mumbai
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Italy
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Arcugnano (VI)
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Italy
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Grosseto GR
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Italy
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Lido di Camaiore (LU)
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Italy
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Pescara
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Italy
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Roma
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Malaysia
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Kelantan
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Malaysia
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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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Emmen
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Groningen
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Netherlands
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Hertogenbosch
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Netherlands
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RM Groningen
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Poland
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Gdansk
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Poland
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Kalisz
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Katowice
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Krakow
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Leszno
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Lublin
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Mosina
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Poland
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Torun
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Portugal
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Coimbra
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Portugal
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Lisboa
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South Africa
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Cape Town
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South Africa
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Gauteng
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South Africa
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Pretoria
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South Africa
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Sandton
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Spain
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Barcelona
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Spain
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Colmenar Viejo
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Spain
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San Sebastian
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Taiwan
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Hualien
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Kaohsiung Hsien
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Taiwan
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Kaohsiung
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Kweishan
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Ubonratchathani Province
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United Kingdom
State/province [73] 0 0
Blackpool

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, randomized, double blind, parallel group study of 6 months' treatment
with SLV308 as 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/NCT00335166
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/NCT00335166