An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
- Registration Number
- NCT00332917
- Lead Sponsor
- Solvay Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
- Patients who have completed S308.3.001 trial
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Pardoprunox -
- Primary Outcome Measures
Name Time Method Safety: laboratory data, adverse events, vital signs, ECG 24 weeks
- Secondary Outcome Measures
Name Time Method UPDRS parts 1, 2 and 3, CGI-severity, CGI-improvement, PDQ-39 total score: all change from baseline 24 weeks
Trial Locations
- Locations (130)
Site 281
🇺🇸Pittsburgh, Pennsylvania, United States
Site 269
🇨🇦Saskatoon, Canada
Site 208
🇦🇷Capital Federal, CBA, Argentina
Site 104
🇧🇬Sofia, Bulgaria
Site 266
🇨🇦Ottawa, Canada
Site 211
🇨🇱San Miguel, Chile
Site 212
🇨🇱Valdivia, Chile
Site 221
🇨🇴Bogota, Colombia
Site 220
🇨🇴Medellin, Colombia
Site 121
🇫🇮Tampere, Finland
Site 124
🇫🇮Turku, Finland
Site 293
🇺🇸Gainsville, Florida, United States
Site 206
🇦🇷Buenos Aires, Argentina
Site 285
🇺🇸Sunrise, Florida, United States
Site 200
🇦🇷Buenos Aires, Argentina
Site 202
🇦🇷Buenos Aires, Argentina
Site 106
🇧🇬Sofia, Bulgaria
Site 263
🇨🇦Markham, Canada
Site 261
🇨🇦Ottawa, Canada
Site 205
🇦🇷Cordoba, Argentina
Site 268
🇨🇦Barrie, Canada
Site 265
🇨🇦Quebec, Canada
Site 210
🇨🇱Santiago de Chile, Chile
Site 233
🇲🇽Tlalpan, Mexico
Site 243
🇵🇪San Isidro-Lima, Peru
Site 274
🇺🇸Little Rock, Arkansas, United States
Site 278
🇺🇸Las Vegas, Nevada, United States
Site 270
🇺🇸Bennington, Vermont, United States
Site 201
🇦🇷Buenos Aires, Argentina
Site 203
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Site 207
🇦🇷Ciudad de Buenos Aires, Argentina
Site 100
🇧🇪Brussels, Belgium
Site 102
🇧🇪Wilrijk, Belgium
Site 107
🇧🇬Plovdiv, Bulgaria
Site 224
🇨🇴Bogota, Colombia
Site 222
🇨🇴Cali, Colombia
Site 122
🇫🇮Lappeenranta, Finland
Site 140
🇷🇴Bucuresti, Romania
Site 252
🇿🇦Cape Town, South Africa
Site 183
🇺🇦Kharkiv, Ukraine
Site 184
🇺🇦Vinnitsa, Ukraine
Site 154
🇷🇺Moscow, Russian Federation
Site 101
🇧🇪Genk, Belgium
Site 103
🇧🇬Sofia, Bulgaria
Site 105
🇧🇬Sofia, Bulgaria
Site 260
🇨🇦Calgary, Canada
Site 264
🇨🇦Greenfield Park, Canada
Site 213
🇨🇱Providencia, Chile
Site 120
🇫🇮Oulun yliopisto, Finland
Site 191
🇳🇿Christchurch, New Zealand
Site 162
🇷🇸Belgrade, Serbia
Site 250
🇿🇦Cape Town, South Africa
Site 262
🇨🇦Quebec, Canada
Site 267
🇨🇦Toronto, Canada
Site 193
🇮🇳Mumbai, India
Site 130
🇮🇱Tel Aviv, Israel
Site 159
🇷🇺St Petersburg, Russian Federation
Site 160
🇷🇸Belgrade, Serbia
Site 161
🇷🇸Belgrade, Serbia
Site 163
🇷🇸Nis, Serbia
Site 151
🇷🇺Moscow, Russian Federation
Site 196
🇮🇳Bangalore, India
Site 174
🇸🇰Levice, Slovakia
Site 150
🇷🇺Moscow, Russian Federation
Site 155
🇷🇺Smolensk, Russian Federation
Site 153
🇷🇺Yaroslav, Russian Federation
Site 231
🇲🇽Monterrey N.L., Mexico
Site 190
🇳🇿Wellington South, New Zealand
Site 244
🇵🇪Barrios Altos-Lima, Peru
Site 241
🇵🇪La Victoria-Lima, Peru
Site 271
🇺🇸San Francisco, California, United States
Site 289
🇺🇸Charlotte, North Carolina, United States
Site 286
🇺🇸Rochester, New York, United States
Site 275
🇺🇸Traverse City, Michigan, United States
Site 287
🇺🇸St. Louis, Missouri, United States
Site 284
🇺🇸Huntsville, Alabama, United States
Site 223
🇨🇴Bogota, Colombia
Site 277
🇺🇸La Jolla, California, United States
Site 290
🇺🇸Chicago, Illinois, United States
Site 273
🇺🇸Tampa, Florida, United States
Site 292
🇺🇸Bingham Farms, Michigan, United States
Site 283
🇺🇸Fountain Valley, California, United States
Site 294
🇺🇸Toledo, Ohio, United States
Site 279
🇺🇸Ft Lauderdale, Florida, United States
Site 276
🇺🇸St. Louis, Missouri, United States
Site 291
🇺🇸Warwick, Rhode Island, United States
Site 272
🇺🇸Houston, Texas, United States
Site 204
🇦🇷Buenos Aires, Argentina
Site 282
🇺🇸Port Charlotte, Florida, United States
Site 280
🇺🇸Kansas City, Kansas, United States
Site 288
🇺🇸Ashville, North Carolina, United States
Site 111
🇭🇷Rijeka, Croatia
Site 113
🇭🇷Zagreb, Croatia
Site 197
🇮🇳Visakhapatnam, India
Site 112
🇭🇷Split, Croatia
Site 110
🇭🇷Zagreb, Croatia
Site 114
🇭🇷Zagreb, Croatia
Site 123
🇫🇮Kuopio, Finland
Site 194
🇮🇳Hyderabaad, India
Site 198
🇮🇳Thiruvananthapuram, India
Site 131
🇮🇱Haifa, Israel
Site 132
🇮🇱Petach-Tikva, Israel
Site 232
🇲🇽Aguascalientes, Mexico
Site 230
🇲🇽Guadalajara - Jalisco, Mexico
Site 240
🇵🇪Lima, Peru
Site 242
🇵🇪Surco-Lima, Peru
Site 141
🇷🇴Craiova, Romania
Site 142
🇷🇴Mures, Romania
Site 156
🇷🇺Moscow, Russian Federation
Site 143
🇷🇴Brasov, Romania
Site 152
🇷🇺St. Petersburg, Russian Federation
Site 157
🇷🇺St. Petersburg, Russian Federation
Site 126
🇸🇪Norrkoping, Sweden
Site 172
🇸🇰Zilina, Slovakia
Site 251
🇿🇦Durban, South Africa
Site 253
🇿🇦Gauteng, South Africa
Site 254
🇿🇦Pretoria, South Africa
Site 170
🇸🇰Bratislava, Slovakia
Site 171
🇸🇰Bratislava, Slovakia
Site 127
🇸🇪Goteborg, Sweden
Site 173
🇸🇰Nitra, Slovakia
Site 182
🇺🇦Kyiv, Ukraine
Site 125
🇸🇪Stockholm, Sweden
Site 180
🇺🇦Kharkiv, Ukraine
Site 181
🇺🇦Kyiv, Ukraine
Site 185
🇺🇦Lviv, Ukraine
Site 195
🇮🇳Mumbai, India
Site 199
🇮🇳New Delhi, India
Site 133
🇮🇱Ramat-Gan, Israel
Site 158
🇷🇺Kazan, Russian Federation