SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
NCT ID: NCT00335166
Last Updated: 2008-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2006-11-30
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Pardaprunox
12-42 mg
2
pramipexole
1.5-4.5 mg
3
Placebo Comparator
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pardaprunox
12-42 mg
pramipexole
1.5-4.5 mg
Placebo Comparator
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Solvay Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Solvay Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
419
Birmingham, Alabama, United States
413
Oceanside, California, United States
408
Oxnard, California, United States
422
New Haven, Connecticut, United States
403
Boca Raton, Florida, United States
411
Sarasota, Florida, United States
421
Augusta, Georgia, United States
410
Fort Wayne, Indiana, United States
417
Lexington, Kentucky, United States
405
Boston, Massachusetts, United States
420
Boston, Massachusetts, United States
415
Grand Rapids, Michigan, United States
416
Golden Valley, Minnesota, United States
406
Minneapolis, Minnesota, United States
418
Albany, New York, United States
424
Charlotte, North Carolina, United States
412
Raleigh, North Carolina, United States
303
Bedford Park, , Australia
304
Cheltenham, , Australia
301
Concord, , Australia
302
Westmead, , Australia
315
Kralove, , Czechia
313
Olomouc, , Czechia
310
Ostrava, , Czechia
314
Ostrava, , Czechia
312
Pardubice, , Czechia
311
Pilsen, , Czechia
320
Tallinn, , Estonia
321
Tartu, , Estonia
323
Aix-en-Provence, , France
324
Toulon, , France
325
Toulouse, , France
332
Bochum, , Germany
331
Göttingen, , Germany
329
Heidelberg, , Germany
327
Homburg, , Germany
330
Leipzig, , Germany
328
Lübeck, , Germany
326
Wiesbaden, , Germany
338
Bangalore, , India
339
Hyderabad, , India
337
Kerala, , India
336
Mumbai, , India
340
Mumbai, , India
347
Arcugnano (VI), , Italy
348
Grosseto GR, , Italy
346
Lido Di Camaiore (LU), , Italy
344
Pescara, , Italy
343
Roma, , Italy
345
Roma, , Italy
428
Kaunas, , Lithuania
427
Vilnius, , Lithuania
429
Vilnius, , Lithuania
355
Kelantan, , Malaysia
357
Kuala Lumpur, , Malaysia
356
Pulau Pinang, , Malaysia
361
's-Hertogenbosch, , Netherlands
364
Eindhoven, , Netherlands
363
Emmen, , Netherlands
362
Groningen, , Netherlands
360
RM Groningen, , Netherlands
373
Gdansk, , Poland
371
Kalisz, , Poland
369
Katowice, , Poland
374
Katowice, , Poland
365
Krakow, , Poland
368
Leszno, , Poland
366
Lublin, , Poland
370
Mosina, , Poland
367
Torun, , Poland
376
Coimbra, , Portugal
375
Lisbon, , Portugal
377
Cape Town, , South Africa
378
Cape Town, , South Africa
380
Gauteng, , South Africa
381
Pretoria, , South Africa
379
Sandton, , South Africa
383
Barcelona, , Spain
384
Colmenar Viejo, , Spain
382
Donostia / San Sebastian, , Spain
388
Hualien City, , Taiwan
387
Kaohsiung City, , Taiwan
389
Kaohsiung Hsien, , Taiwan
386
Kweishan, , Taiwan
385
Taipei, , Taiwan
391
Bangkok, , Thailand
393
Bangkok, , Thailand
394
Ubonratchathani Province, , Thailand
396
Blackpool, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Not requested yet
Identifier Type: -
Identifier Source: secondary_id
S308.3.003
Identifier Type: -
Identifier Source: org_study_id