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SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease

Primary Purpose

Early Stage Parkinson Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pardaprunox
pramipexole
Placebo Comparator
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Stage Parkinson Disease focused on measuring Parkinson Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment

Secondary Outcome Measures

UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.

Full Information

First Posted
June 8, 2006
Last Updated
April 1, 2008
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00335166
Brief Title
SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Parkinson Disease
Keywords
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pardaprunox
Intervention Description
12-42 mg
Intervention Type
Drug
Intervention Name(s)
pramipexole
Intervention Description
1.5-4.5 mg
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
419
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
413
City
Oceanside
State/Province
California
Country
United States
Facility Name
408
City
Oxnard
State/Province
California
Country
United States
Facility Name
422
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
403
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
411
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
421
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
410
City
Ft Wayne
State/Province
Indiana
Country
United States
Facility Name
417
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
405
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
420
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
415
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
416
City
Golden Valley
State/Province
Minnesota
Country
United States
Facility Name
406
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
418
City
Albany
State/Province
New York
Country
United States
Facility Name
424
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
412
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
303
City
Bedford Park
Country
Australia
Facility Name
304
City
Cheltenham
Country
Australia
Facility Name
301
City
Concord
Country
Australia
Facility Name
302
City
Westmead
Country
Australia
Facility Name
315
City
Kralove
Country
Czech Republic
Facility Name
313
City
Olomouc
Country
Czech Republic
Facility Name
310
City
Ostrava
Country
Czech Republic
Facility Name
314
City
Ostrava
Country
Czech Republic
Facility Name
312
City
Pardubice
Country
Czech Republic
Facility Name
311
City
Plzen
Country
Czech Republic
Facility Name
320
City
Tallinn
Country
Estonia
Facility Name
321
City
Tartu
Country
Estonia
Facility Name
323
City
Aix en Provence
Country
France
Facility Name
324
City
Toulon
Country
France
Facility Name
325
City
Toulouse
Country
France
Facility Name
332
City
Bochum
Country
Germany
Facility Name
331
City
Gottingen
Country
Germany
Facility Name
329
City
Heidelberg
Country
Germany
Facility Name
327
City
Homburg
Country
Germany
Facility Name
330
City
Leipzig
Country
Germany
Facility Name
328
City
Lubeck
Country
Germany
Facility Name
326
City
Wiesbaden
Country
Germany
Facility Name
338
City
Bangalore
Country
India
Facility Name
339
City
Hyderabad
Country
India
Facility Name
337
City
Kerala
Country
India
Facility Name
336
City
Mumbai
Country
India
Facility Name
340
City
Mumbai
Country
India
Facility Name
347
City
Arcugnano (VI)
Country
Italy
Facility Name
348
City
Grosseto GR
Country
Italy
Facility Name
346
City
Lido di Camaiore (LU)
Country
Italy
Facility Name
344
City
Pescara
Country
Italy
Facility Name
343
City
Roma
Country
Italy
Facility Name
345
City
Roma
Country
Italy
Facility Name
428
City
Kaunas
Country
Lithuania
Facility Name
427
City
Vilnius
Country
Lithuania
Facility Name
429
City
Vilnius
Country
Lithuania
Facility Name
355
City
Kelantan
Country
Malaysia
Facility Name
357
City
Kuala Lumpur
Country
Malaysia
Facility Name
356
City
Pulau Pinang
Country
Malaysia
Facility Name
364
City
Eindhoven
Country
Netherlands
Facility Name
363
City
Emmen
Country
Netherlands
Facility Name
362
City
Groningen
Country
Netherlands
Facility Name
361
City
Hertogenbosch
Country
Netherlands
Facility Name
360
City
RM Groningen
Country
Netherlands
Facility Name
373
City
Gdansk
Country
Poland
Facility Name
371
City
Kalisz
Country
Poland
Facility Name
369
City
Katowice
Country
Poland
Facility Name
374
City
Katowice
Country
Poland
Facility Name
365
City
Krakow
Country
Poland
Facility Name
368
City
Leszno
Country
Poland
Facility Name
366
City
Lublin
Country
Poland
Facility Name
370
City
Mosina
Country
Poland
Facility Name
367
City
Torun
Country
Poland
Facility Name
376
City
Coimbra
Country
Portugal
Facility Name
375
City
Lisboa
Country
Portugal
Facility Name
377
City
Cape Town
Country
South Africa
Facility Name
378
City
Cape Town
Country
South Africa
Facility Name
380
City
Gauteng
Country
South Africa
Facility Name
381
City
Pretoria
Country
South Africa
Facility Name
379
City
Sandton
Country
South Africa
Facility Name
383
City
Barcelona
Country
Spain
Facility Name
384
City
Colmenar Viejo
Country
Spain
Facility Name
382
City
San Sebastian
Country
Spain
Facility Name
388
City
Hualien
Country
Taiwan
Facility Name
389
City
Kaohsiung Hsien
Country
Taiwan
Facility Name
387
City
Kaohsiung
Country
Taiwan
Facility Name
386
City
Kweishan
Country
Taiwan
Facility Name
385
City
Taipei
Country
Taiwan
Facility Name
391
City
Bangkok
Country
Thailand
Facility Name
393
City
Bangkok
Country
Thailand
Facility Name
394
City
Ubonratchathani Province
Country
Thailand
Facility Name
396
City
Blackpool
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21542016
Citation
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.
Results Reference
derived

Learn more about this trial

SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease

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