Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Kralove
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Olomouc
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Ostrava
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Pardubice
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Plzen
Country [18] 0 0
Estonia
State/province [18] 0 0
Tallinn
Country [19] 0 0
Estonia
State/province [19] 0 0
Tartu
Country [20] 0 0
France
State/province [20] 0 0
Aix en Provence
Country [21] 0 0
France
State/province [21] 0 0
Toulon
Country [22] 0 0
France
State/province [22] 0 0
Toulouse
Country [23] 0 0
Germany
State/province [23] 0 0
Bochum
Country [24] 0 0
Germany
State/province [24] 0 0
Gottingen
Country [25] 0 0
Germany
State/province [25] 0 0
Heidelberg
Country [26] 0 0
Germany
State/province [26] 0 0
Homburg
Country [27] 0 0
Germany
State/province [27] 0 0
Leipzig
Country [28] 0 0
Germany
State/province [28] 0 0
Lubeck
Country [29] 0 0
Germany
State/province [29] 0 0
Wiesbaden
Country [30] 0 0
India
State/province [30] 0 0
Bangalore
Country [31] 0 0
India
State/province [31] 0 0
Hyderabad
Country [32] 0 0
India
State/province [32] 0 0
Kerala
Country [33] 0 0
India
State/province [33] 0 0
Mumbai
Country [34] 0 0
Italy
State/province [34] 0 0
Arcugnano (VI)
Country [35] 0 0
Italy
State/province [35] 0 0
Grosseto GR
Country [36] 0 0
Italy
State/province [36] 0 0
Lido di Camaiore (LU)
Country [37] 0 0
Italy
State/province [37] 0 0
Pescara
Country [38] 0 0
Italy
State/province [38] 0 0
Roma
Country [39] 0 0
Lithuania
State/province [39] 0 0
Kaunas
Country [40] 0 0
Lithuania
State/province [40] 0 0
Vilnius
Country [41] 0 0
Malaysia
State/province [41] 0 0
Kelantan
Country [42] 0 0
Malaysia
State/province [42] 0 0
Kuala Lumpur
Country [43] 0 0
Malaysia
State/province [43] 0 0
Pulau Pinang
Country [44] 0 0
Netherlands
State/province [44] 0 0
Eindhoven
Country [45] 0 0
Netherlands
State/province [45] 0 0
Emmen
Country [46] 0 0
Netherlands
State/province [46] 0 0
Groningen
Country [47] 0 0
Netherlands
State/province [47] 0 0
Hertogenbosch
Country [48] 0 0
Netherlands
State/province [48] 0 0
RM Groningen
Country [49] 0 0
Poland
State/province [49] 0 0
Gdansk
Country [50] 0 0
Poland
State/province [50] 0 0
Kalisz
Country [51] 0 0
Poland
State/province [51] 0 0
Katowice
Country [52] 0 0
Poland
State/province [52] 0 0
Krakow
Country [53] 0 0
Poland
State/province [53] 0 0
Leszno
Country [54] 0 0
Poland
State/province [54] 0 0
Lublin
Country [55] 0 0
Poland
State/province [55] 0 0
Mosina
Country [56] 0 0
Poland
State/province [56] 0 0
Torun
Country [57] 0 0
Portugal
State/province [57] 0 0
Coimbra
Country [58] 0 0
Portugal
State/province [58] 0 0
Lisboa
Country [59] 0 0
South Africa
State/province [59] 0 0
Cape Town
Country [60] 0 0
South Africa
State/province [60] 0 0
Gauteng
Country [61] 0 0
South Africa
State/province [61] 0 0
Pretoria
Country [62] 0 0
South Africa
State/province [62] 0 0
Sandton
Country [63] 0 0
Spain
State/province [63] 0 0
Barcelona
Country [64] 0 0
Spain
State/province [64] 0 0
Colmenar Viejo
Country [65] 0 0
Spain
State/province [65] 0 0
San Sebastian
Country [66] 0 0
Taiwan
State/province [66] 0 0
Hualien
Country [67] 0 0
Taiwan
State/province [67] 0 0
Kaohsiung Hsien
Country [68] 0 0
Taiwan
State/province [68] 0 0
Kaohsiung
Country [69] 0 0
Taiwan
State/province [69] 0 0
Kweishan
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei
Country [71] 0 0
Thailand
State/province [71] 0 0
Bangkok
Country [72] 0 0
Thailand
State/province [72] 0 0
Ubonratchathani Province
Country [73] 0 0
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/study/NCT00335166
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/NCT00335166