An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
- Registration Number
- NCT00335374
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
- Patients who have completed S308.3.003 trial
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Pardoprunox -
- Primary Outcome Measures
Name Time Method Safety: laboratory data, adverse events, vital signs, ECG 24 weeks
- Secondary Outcome Measures
Name Time Method UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline 24 weeks
Trial Locations
- Locations (75)
389
🇨🇳Kaohsiung Hsien, Taiwan
387
🇨🇳Kaohsiung, Taiwan
368
🇵🇱Leszno, Poland
366
🇵🇱Lublin, Poland
376
🇵🇹Coimbra, Portugal
375
🇵🇹Lisboa, Portugal
386
🇨🇳Kwei-Shan, Taiwan
391
🇹ðŸ‡Bangkok, Thailand
393
🇹ðŸ‡Bangkok, Thailand
315
🇨🇿Kralove, Czech Republic
313
🇨🇿Olomouc, Czech Republic
310
🇨🇿Ostrava, Czech Republic
312
🇨🇿Pardubice, Czech Republic
311
🇨🇿Plzen, Czech Republic
320
🇪🇪Tallinn, Estonia
321
🇪🇪Tartu, Estonia
332
🇩🇪Bochum, Germany
331
🇩🇪Gottingen, Germany
329
🇩🇪Heidelberg, Germany
330
🇩🇪Leipzig, Germany
328
🇩🇪Lubeck, Germany
340
🇮🇳Mumbai, India
348
🇮🇹Grosseto, Italy
346
🇮🇹Lido di Camaiore, Italy
362
🇳🇱Groningen, Netherlands
428
🇱🇹Kaunas, Lithuania
345
🇮🇹Roma, Italy
427
🇱🇹Vilnius, Lithuania
343
🇮🇹Roma, Italy
429
🇱🇹Vilnius, Lithuania
355
🇲🇾Kelantan, Malaysia
357
🇲🇾Kuala Lumpur, Malaysia
356
🇲🇾Pulau Pinang, Malaysia
364
🇳🇱Eindhoven, Netherlands
360
🇳🇱Groningen, Netherlands
361
🇳🇱Hertogenbosch, Netherlands
373
🇵🇱Gdansk, Poland
371
🇵🇱Kalisz, Poland
369
🇵🇱Katowice, Poland
405
🇺🇸Boston, Massachusetts, United States
408
🇺🇸Oxnard, California, United States
421
🇺🇸Augusta, Georgia, United States
413
🇺🇸Oceanside, California, United States
419
🇺🇸Birmingham, Alabama, United States
412
🇺🇸Raleigh, North Carolina, United States
411
🇺🇸Sarasota, Florida, United States
410
🇺🇸Ft Wayne, Indiana, United States
417
🇺🇸Lexington, Kentucky, United States
406
🇺🇸Minneapolis, Minnesota, United States
381
🇿🇦Pretoria, South Africa
344
🇮🇹Pescara, Italy
379
🇿🇦Sandton, South Africa
378
🇿🇦Cape Town, South Africa
380
🇿🇦Gauteng, South Africa
304
🇦🇺Cheltenham, Australia
Site 300
🇦🇺East Gosford, Australia
403
🇺🇸Boca Raton, Florida, United States
420
🇺🇸Boston, Massachusetts, United States
303
🇦🇺Bedford Park, Australia
Site 402
🇺🇸Dayton, Ohio, United States
301
🇦🇺Concord, Australia
302
🇦🇺Westmead, Australia
314
🇨🇿Ostrava, Czech Republic
365
🇵🇱Krakow, Poland
377
🇿🇦Cape Town, South Africa
385
🇨🇳Taipei, Taiwan
370
🇵🇱Mosina, Poland
336
🇮🇳Mumbai, India
326
🇩🇪Wiesbaden, Germany
338
🇮🇳Bangalore, India
339
🇮🇳Hyderabaad, India
337
🇮🇳Kerala, India
422
🇺🇸New Haven, Connecticut, United States
388
🇨🇳Hualien, Taiwan
394
🇹ðŸ‡Ubonratchathani, Thailand