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An Open Label SLV308 Safety Extension to Study S308.3.001 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 S308.3.001 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 S308.3.001

Sites / Locations

  • Site 284
  • Site 274
  • Site 283
  • Site 277
  • Site 271
  • Site 279
  • Site 293
  • Site 282
  • Site 285
  • Site 273
  • Site 290
  • Site 280
  • Site 292
  • Site 275
  • Site 276
  • Site 287
  • Site 278
  • Site 286
  • Site 288
  • Site 289
  • Site 294
  • Site 281
  • Site 291
  • Site 272
  • Site 270
  • Site 200
  • Site 201
  • Site 202
  • Site 204
  • Site 206
  • Site 208
  • Site 203
  • Site 207
  • Site 205
  • Site 100
  • Site 101
  • Site 102
  • Site 107
  • Site 103
  • Site 104
  • Site 105
  • Site 106
  • Site 268
  • Site 260
  • Site 264
  • Site 263
  • Site 261
  • Site 266
  • Site 262
  • Site 265
  • Site 269
  • Site 267
  • Site 213
  • Site 211
  • Site 210
  • Site 212
  • Site 221
  • Site 223
  • Site 224
  • Site 222
  • Site 220
  • Site 111
  • Site 112
  • Site 110
  • Site 113
  • Site 114
  • Site 123
  • Site 122
  • Site 120
  • Site 121
  • Site 124
  • Site 196
  • Site 194
  • Site 193
  • Site 195
  • Site 199
  • Site 198
  • Site 197
  • Site 131
  • Site 132
  • Site 133
  • Site 130
  • Site 232
  • Site 230
  • Site 231
  • Site 233
  • Site 191
  • Site 190
  • Site 244
  • Site 241
  • Site 240
  • Site 243
  • Site 242
  • Site 143
  • Site 140
  • Site 141
  • Site 142
  • Site 158
  • Site 150
  • Site 151
  • Site 154
  • Site 156
  • Site 155
  • Site 159
  • Site 152
  • Site 157
  • Site 153
  • Site 160
  • Site 161
  • Site 162
  • Site 163
  • Site 170
  • Site 171
  • Site 174
  • Site 173
  • Site 172
  • Site 250
  • Site 252
  • Site 251
  • Site 253
  • Site 254
  • Site 127
  • Site 126
  • Site 125
  • Site 180
  • Site 183
  • Site 181
  • Site 182
  • Site 185
  • Site 184

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 1, 2006
Last Updated
January 23, 2009
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00332917
Brief Title
An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
Official Title
An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 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 S308.3.001 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
224 (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 S308.3.001 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 S308.3.001
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
Site 284
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Site 274
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Site 283
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
Site 277
City
La Jolla
State/Province
California
Country
United States
Facility Name
Site 271
City
San Francisco
State/Province
California
Country
United States
Facility Name
Site 279
City
Ft Lauderdale
State/Province
Florida
Country
United States
Facility Name
Site 293
City
Gainsville
State/Province
Florida
Country
United States
Facility Name
Site 282
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
Site 285
City
Sunrise
State/Province
Florida
Country
United States
Facility Name
Site 273
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Site 290
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 280
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Site 292
City
Bingham Farms
State/Province
Michigan
Country
United States
Facility Name
Site 275
City
Traverse City
State/Province
Michigan
Country
United States
Facility Name
Site 276
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 287
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 278
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Site 286
City
Rochester
State/Province
New York
Country
United States
Facility Name
Site 288
City
Ashville
State/Province
North Carolina
Country
United States
Facility Name
Site 289
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Site 294
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Site 281
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Site 291
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Site 272
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 270
City
Bennington
State/Province
Vermont
Country
United States
Facility Name
Site 200
City
Buenos Aires
Country
Argentina
Facility Name
Site 201
City
Buenos Aires
Country
Argentina
Facility Name
Site 202
City
Buenos Aires
Country
Argentina
Facility Name
Site 204
City
Buenos Aires
Country
Argentina
Facility Name
Site 206
City
Buenos Aires
Country
Argentina
Facility Name
Site 208
City
Capital Federal, CBA
Country
Argentina
Facility Name
Site 203
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
Facility Name
Site 207
City
Ciudad de Buenos Aires
Country
Argentina
Facility Name
Site 205
City
Cordoba
Country
Argentina
Facility Name
Site 100
City
Brussels
Country
Belgium
Facility Name
Site 101
City
Genk
Country
Belgium
Facility Name
Site 102
City
Wilrijk
Country
Belgium
Facility Name
Site 107
City
Plovdiv
Country
Bulgaria
Facility Name
Site 103
City
Sofia
Country
Bulgaria
Facility Name
Site 104
City
Sofia
Country
Bulgaria
Facility Name
Site 105
City
Sofia
Country
Bulgaria
Facility Name
Site 106
City
Sofia
Country
Bulgaria
Facility Name
Site 268
City
Barrie
Country
Canada
Facility Name
Site 260
City
Calgary
Country
Canada
Facility Name
Site 264
City
Greenfield Park
Country
Canada
Facility Name
Site 263
City
Markham
Country
Canada
Facility Name
Site 261
City
Ottawa
Country
Canada
Facility Name
Site 266
City
Ottawa
Country
Canada
Facility Name
Site 262
City
Quebec
Country
Canada
Facility Name
Site 265
City
Quebec
Country
Canada
Facility Name
Site 269
City
Saskatoon
Country
Canada
Facility Name
Site 267
City
Toronto
Country
Canada
Facility Name
Site 213
City
Providencia
Country
Chile
Facility Name
Site 211
City
San Miguel
Country
Chile
Facility Name
Site 210
City
Santiago de Chile
Country
Chile
Facility Name
Site 212
City
Valdivia
Country
Chile
Facility Name
Site 221
City
Bogota
Country
Colombia
Facility Name
Site 223
City
Bogota
Country
Colombia
Facility Name
Site 224
City
Bogota
Country
Colombia
Facility Name
Site 222
City
Cali
Country
Colombia
Facility Name
Site 220
City
Medellin
Country
Colombia
Facility Name
Site 111
City
Rijeka
Country
Croatia
Facility Name
Site 112
City
Split
Country
Croatia
Facility Name
Site 110
City
Zagreb
Country
Croatia
Facility Name
Site 113
City
Zagreb
Country
Croatia
Facility Name
Site 114
City
Zagreb
Country
Croatia
Facility Name
Site 123
City
Kuopio
Country
Finland
Facility Name
Site 122
City
Lappeenranta
Country
Finland
Facility Name
Site 120
City
Oulun yliopisto
Country
Finland
Facility Name
Site 121
City
Tampere
Country
Finland
Facility Name
Site 124
City
Turku
Country
Finland
Facility Name
Site 196
City
Bangalore
Country
India
Facility Name
Site 194
City
Hyderabaad
Country
India
Facility Name
Site 193
City
Mumbai
Country
India
Facility Name
Site 195
City
Mumbai
Country
India
Facility Name
Site 199
City
New Delhi
Country
India
Facility Name
Site 198
City
Thiruvananthapuram
Country
India
Facility Name
Site 197
City
Visakhapatnam
Country
India
Facility Name
Site 131
City
Haifa
Country
Israel
Facility Name
Site 132
City
Petach-Tikva
Country
Israel
Facility Name
Site 133
City
Ramat-Gan
Country
Israel
Facility Name
Site 130
City
Tel Aviv
Country
Israel
Facility Name
Site 232
City
Aguascalientes
Country
Mexico
Facility Name
Site 230
City
Guadalajara - Jalisco
Country
Mexico
Facility Name
Site 231
City
Monterrey N.L.
Country
Mexico
Facility Name
Site 233
City
Tlalpan
Country
Mexico
Facility Name
Site 191
City
Christchurch
Country
New Zealand
Facility Name
Site 190
City
Wellington South
Country
New Zealand
Facility Name
Site 244
City
Barrios Altos-Lima
Country
Peru
Facility Name
Site 241
City
La Victoria-Lima
Country
Peru
Facility Name
Site 240
City
Lima
Country
Peru
Facility Name
Site 243
City
San Isidro-Lima
Country
Peru
Facility Name
Site 242
City
Surco-Lima
Country
Peru
Facility Name
Site 143
City
Brasov
Country
Romania
Facility Name
Site 140
City
Bucuresti
Country
Romania
Facility Name
Site 141
City
Craiova
Country
Romania
Facility Name
Site 142
City
Mures
Country
Romania
Facility Name
Site 158
City
Kazan
Country
Russian Federation
Facility Name
Site 150
City
Moscow
Country
Russian Federation
Facility Name
Site 151
City
Moscow
Country
Russian Federation
Facility Name
Site 154
City
Moscow
Country
Russian Federation
Facility Name
Site 156
City
Moscow
Country
Russian Federation
Facility Name
Site 155
City
Smolensk
Country
Russian Federation
Facility Name
Site 159
City
St Petersburg
Country
Russian Federation
Facility Name
Site 152
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 157
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 153
City
Yaroslav
Country
Russian Federation
Facility Name
Site 160
City
Belgrade
Country
Serbia
Facility Name
Site 161
City
Belgrade
Country
Serbia
Facility Name
Site 162
City
Belgrade
Country
Serbia
Facility Name
Site 163
City
Nis
Country
Serbia
Facility Name
Site 170
City
Bratislava
Country
Slovakia
Facility Name
Site 171
City
Bratislava
Country
Slovakia
Facility Name
Site 174
City
Levice
Country
Slovakia
Facility Name
Site 173
City
Nitra
Country
Slovakia
Facility Name
Site 172
City
Zilina
Country
Slovakia
Facility Name
Site 250
City
Cape Town
Country
South Africa
Facility Name
Site 252
City
Cape Town
Country
South Africa
Facility Name
Site 251
City
Durban
Country
South Africa
Facility Name
Site 253
City
Gauteng
Country
South Africa
Facility Name
Site 254
City
Pretoria
Country
South Africa
Facility Name
Site 127
City
Goteborg
Country
Sweden
Facility Name
Site 126
City
Norrkoping
Country
Sweden
Facility Name
Site 125
City
Stockholm
Country
Sweden
Facility Name
Site 180
City
Kharkiv
Country
Ukraine
Facility Name
Site 183
City
Kharkiv
Country
Ukraine
Facility Name
Site 181
City
Kyiv
Country
Ukraine
Facility Name
Site 182
City
Kyiv
Country
Ukraine
Facility Name
Site 185
City
Lviv
Country
Ukraine
Facility Name
Site 184
City
Vinnitsa
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

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