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An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00335374
Recruitment Status : Completed
First Posted : June 9, 2006
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Early Stage Parkinson's Disease Drug: Pardoprunox Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
Study Start Date : August 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: Pardoprunox
12 -42 mg




Primary Outcome Measures :
  1. Safety: laboratory data, adverse events, vital signs, ECG [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335374


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Locations
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United States, Alabama
419
Birmingham, Alabama, United States
United States, California
413
Oceanside, California, United States
408
Oxnard, California, United States
United States, Connecticut
422
New Haven, Connecticut, United States
United States, Florida
403
Boca Raton, Florida, United States
411
Sarasota, Florida, United States
United States, Georgia
421
Augusta, Georgia, United States
United States, Indiana
410
Ft Wayne, Indiana, United States
United States, Kentucky
417
Lexington, Kentucky, United States
United States, Massachusetts
405
Boston, Massachusetts, United States
420
Boston, Massachusetts, United States
United States, Minnesota
406
Minneapolis, Minnesota, United States
United States, North Carolina
412
Raleigh, North Carolina, United States
United States, Ohio
Site 402
Dayton, Ohio, United States
Australia
303
Bedford Park, Australia
304
Cheltenham, Australia
301
Concord, Australia
Site 300
East Gosford, Australia
302
Westmead, Australia
Czech Republic
315
Kralove, Czech Republic
313
Olomouc, Czech Republic
310
Ostrava, Czech Republic
314
Ostrava, Czech Republic
312
Pardubice, Czech Republic
311
Plzen, Czech Republic
Estonia
320
Tallinn, Estonia
321
Tartu, Estonia
Germany
332
Bochum, Germany
331
Gottingen, Germany
329
Heidelberg, Germany
330
Leipzig, Germany
328
Lubeck, Germany
326
Wiesbaden, Germany
India
338
Bangalore, India
339
Hyderabaad, India
337
Kerala, India
336
Mumbai, India
340
Mumbai, India
Italy
348
Grosseto, Italy
346
Lido di Camaiore, Italy
344
Pescara, Italy
343
Roma, Italy
345
Roma, Italy
Lithuania
428
Kaunas, Lithuania
427
Vilnius, Lithuania
429
Vilnius, Lithuania
Malaysia
355
Kelantan, Malaysia
357
Kuala Lumpur, Malaysia
356
Pulau Pinang, Malaysia
Netherlands
364
Eindhoven, Netherlands
360
Groningen, Netherlands
362
Groningen, Netherlands
361
Hertogenbosch, Netherlands
Poland
373
Gdansk, Poland
371
Kalisz, Poland
369
Katowice, Poland
365
Krakow, Poland
368
Leszno, Poland
366
Lublin, Poland
370
Mosina, Poland
Portugal
376
Coimbra, Portugal
375
Lisboa, Portugal
South Africa
377
Cape Town, South Africa
378
Cape Town, South Africa
380
Gauteng, South Africa
381
Pretoria, South Africa
379
Sandton, South Africa
Taiwan
388
Hualien, Taiwan
389
Kaohsiung Hsien, Taiwan
387
Kaohsiung, Taiwan
386
Kwei-Shan, Taiwan
385
Taipei, Taiwan
Thailand
391
Bangkok, Thailand
393
Bangkok, Thailand
394
Ubonratchathani, Thailand
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

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Responsible Party: Ellen van Kleef, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00335374     History of Changes
Other Study ID Numbers: S308.3.008
2006-000859-18
First Posted: June 9, 2006    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009
Keywords provided by Solvay Pharmaceuticals:
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases