SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
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.
2 other identifiers
interventional
330
17 countries
86
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2006
Shorter than P25 for phase_3
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2006
CompletedFirst Posted
Study publicly available on registry
June 9, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedApril 3, 2008
April 1, 2008
1.3 years
June 8, 2006
April 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
24 weeks
Secondary Outcomes (1)
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.
24 weeks
Study Arms (3)
1
EXPERIMENTAL2
ACTIVE COMPARATOR3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (89)
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
Related Publications (1)
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.
PMID: 21542016DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 8, 2006
First Posted
June 9, 2006
Study Start
November 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 3, 2008
Record last verified: 2008-04