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

Primary Purpose

Early Stage Parkinson's Disease

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

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • 419
  • 413
  • 408
  • 422
  • 403
  • 411
  • 421
  • 410
  • 417
  • 405
  • 420
  • 406
  • 412
  • Site 402
  • 303
  • 304
  • 301
  • Site 300
  • 302
  • 315
  • 313
  • 310
  • 314
  • 312
  • 311
  • 320
  • 321
  • 332
  • 331
  • 329
  • 330
  • 328
  • 326
  • 338
  • 339
  • 337
  • 336
  • 340
  • 348
  • 346
  • 344
  • 343
  • 345
  • 428
  • 427
  • 429
  • 355
  • 357
  • 356
  • 364
  • 360
  • 362
  • 361
  • 373
  • 371
  • 369
  • 365
  • 368
  • 366
  • 370
  • 376
  • 375
  • 377
  • 378
  • 380
  • 381
  • 379
  • 388
  • 389
  • 387
  • 386
  • 385
  • 391
  • 393
  • 394

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Safety: laboratory data, adverse events, vital signs, ECG

Secondary Outcome Measures

UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline

Full Information

First Posted
June 8, 2006
Last Updated
February 5, 2009
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00335374
Brief Title
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
Official Title
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 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, 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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pardoprunox
Intervention Description
12 -42 mg
Primary Outcome Measure Information:
Title
Safety: laboratory data, adverse events, vital signs, ECG
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
406
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
412
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Site 402
City
Dayton
State/Province
Ohio
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
Site 300
City
East Gosford
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
332
City
Bochum
Country
Germany
Facility Name
331
City
Gottingen
Country
Germany
Facility Name
329
City
Heidelberg
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
Hyderabaad
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
348
City
Grosseto
Country
Italy
Facility Name
346
City
Lido di Camaiore
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
360
City
Groningen
Country
Netherlands
Facility Name
362
City
Groningen
Country
Netherlands
Facility Name
361
City
Hertogenbosch
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
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
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
388
City
Hualien
Country
Taiwan
Facility Name
389
City
Kaohsiung Hsien
Country
Taiwan
Facility Name
387
City
Kaohsiung
Country
Taiwan
Facility Name
386
City
Kwei-Shan
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
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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