- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00335374
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
February 5, 2009 updated by: Solvay Pharmaceuticals
This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.003
trial
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
202
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bedford Park, Australia
- 303
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Cheltenham, Australia
- 304
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Concord, Australia
- 301
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East Gosford, Australia
- Site 300
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Westmead, Australia
- 302
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-
-
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Kralove, Czech Republic
- 315
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Olomouc, Czech Republic
- 313
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Ostrava, Czech Republic
- 310
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Ostrava, Czech Republic
- 314
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Pardubice, Czech Republic
- 312
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Plzen, Czech Republic
- 311
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-
-
-
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Tallinn, Estonia
- 320
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Tartu, Estonia
- 321
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-
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-
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Bochum, Germany
- 332
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Gottingen, Germany
- 331
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Heidelberg, Germany
- 329
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Leipzig, Germany
- 330
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Lubeck, Germany
- 328
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Wiesbaden, Germany
- 326
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Bangalore, India
- 338
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Hyderabaad, India
- 339
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Kerala, India
- 337
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Mumbai, India
- 336
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Mumbai, India
- 340
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-
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Grosseto, Italy
- 348
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Lido di Camaiore, Italy
- 346
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Pescara, Italy
- 344
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Roma, Italy
- 343
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Roma, Italy
- 345
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-
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-
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Kaunas, Lithuania
- 428
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Vilnius, Lithuania
- 427
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Vilnius, Lithuania
- 429
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-
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Kelantan, Malaysia
- 355
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Kuala Lumpur, Malaysia
- 357
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Pulau Pinang, Malaysia
- 356
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-
-
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Eindhoven, Netherlands
- 364
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Groningen, Netherlands
- 362
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Groningen, Netherlands
- 360
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Hertogenbosch, Netherlands
- 361
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-
-
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Gdansk, Poland
- 373
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Kalisz, Poland
- 371
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Katowice, Poland
- 369
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Krakow, Poland
- 365
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Leszno, Poland
- 368
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Lublin, Poland
- 366
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Mosina, Poland
- 370
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Coimbra, Portugal
- 376
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Lisboa, Portugal
- 375
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Cape Town, South Africa
- 377
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Cape Town, South Africa
- 378
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Gauteng, South Africa
- 380
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Pretoria, South Africa
- 381
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Sandton, South Africa
- 379
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Hualien, Taiwan
- 388
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Kaohsiung, Taiwan
- 387
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Kaohsiung Hsien, Taiwan
- 389
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Kwei-Shan, Taiwan
- 386
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Taipei, Taiwan
- 385
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Bangkok, Thailand
- 391
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Bangkok, Thailand
- 393
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Ubonratchathani, Thailand
- 394
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Alabama
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Birmingham, Alabama, United States
- 419
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California
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Oceanside, California, United States
- 413
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Oxnard, California, United States
- 408
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Connecticut
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New Haven, Connecticut, United States
- 422
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Florida
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Boca Raton, Florida, United States
- 403
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Sarasota, Florida, United States
- 411
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Georgia
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Augusta, Georgia, United States
- 421
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Indiana
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Ft Wayne, Indiana, United States
- 410
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Kentucky
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Lexington, Kentucky, United States
- 417
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Massachusetts
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Boston, Massachusetts, United States
- 405
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Boston, Massachusetts, United States
- 420
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Minnesota
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Minneapolis, Minnesota, United States
- 406
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North Carolina
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Raleigh, North Carolina, United States
- 412
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Ohio
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Dayton, Ohio, United States
- Site 402
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who have completed S308.3.003 trial
Exclusion Criteria:
- Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.003
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
12 -42 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: laboratory data, adverse events, vital signs, ECG
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
June 8, 2006
First Submitted That Met QC Criteria
June 8, 2006
First Posted (Estimate)
June 9, 2006
Study Record Updates
Last Update Posted (Estimate)
February 6, 2009
Last Update Submitted That Met QC Criteria
February 5, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S308.3.008
- 2006-000859-18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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