An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
- Registration Number
- NCT00407095
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
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 36 weeks
- Secondary Outcome Measures
Name Time Method On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline 36 weeks
Trial Locations
- Locations (87)
S308.3.007 Site # 221
🇺🇸Chicago, Illinois, United States
S308.3.007 Site # 120
🇧🇬Sofia, Bulgaria
S308.3.007 Site # 141
🇨🇱Santiago de Chile, Chile
S308.3.007 Site # 132
🇨🇦Markham, Canada
S308.3.007 Site # 118
🇧🇷Porto Alegre, Brazil
S308.3.007 Site # 106
🇦🇷Buenos Aires, Argentina
S308.3.007 Site # 134
🇨🇦Ottava, Canada
S308.3.007 Site # 114
🇧🇷Alto da Glória, Brazil
S308.3.007 Site # 215
🇺🇸Houston, Texas, United States
S308.3.007 Site # 111
🇧🇷Porto Alegre, Brazil
S308.3.007 Site # 104
🇦🇷Mar del Plata, Argentina
S308.3.007 Site # 109
🇦🇷Buenos Aires, Argentina
S308.3.007 Site # 210
🇺🇸Tledo, Ohio, United States
S308.3.007 Site # 223
🇦🇱Birmingham, Albania
S308.3.007 Site # 123
🇧🇬Plovdiv, Bulgaria
S308.3.007 Site # 137
🇨🇦Greenfield Park, Canada
S308.3.007 Site # 125
🇧🇷Sao Paulo, Brazil
S308.3.007 Site # 217
🇺🇸St. Louis, Missouri, United States
S308.3.007 Site # 124
🇧🇬Sofia, Bulgaria
S308.3.007 Site # 115
🇧🇷Sâo Paulo, Brazil
S308.3.007 Site # 136
🇨🇦Calgary, Canada
S308.3.007 Site # 122
🇧🇬Sofia, Bulgaria
S308.3.007 Site # 117
🇧🇷Ribeirão Preto, Brazil
S308.3.007 Site # 202
🇺🇦Kyiv, Ukraine
S308.3.007 Site # 195
🇷🇺Saint-Petersburg, Russian Federation
S308.3.007 Site # 206
🇺🇦Kharkiv, Ukraine
S308.3.007 Site # 203
🇺🇦Poltava, Ukraine
S308.3.007 Site # 207
🇺🇦Zaporozhya, Ukraine
S308.3.007 Site # 205
🇺🇦Lviv, Ukraine
S308.3.007 Site # 216
🇺🇸Kansas City, Kansas, United States
S308.3.007 Site # 150
🇨🇴Medellin, Colombia
S308.3.007 Site # 160
🇱🇻Riga, Latvia
S308.3.007 Site # 182
🇵🇪Lima, Peru
S308.3.007 Site # 143
🇨🇱Santiago de Chile, Chile
S308.3.007 Site # 151
🇨🇴Bogota, Colombia
S308.3.007 Site # 152
🇨🇴Bogota, Colombia
S308.3.007 Site # 196
🇷🇺Yaroslavl, Russian Federation
S308.3.007 Site # 204
🇺🇦Dnepropetrovsk, Ukraine
S308.3.007 Site # 201
🇺🇦Kyiv, Ukraine
S308.3.007 Site # 197
🇷🇺Moscow, Russian Federation
S308.3.007 Site # 142
🇨🇱Valdivia, Chile
S308.3.007 Site # 172
🇱🇹Kaunas, Lithuania
S308.3.007 Site # 190
🇷🇺Moscow, Russian Federation
S308.3.007 Site # 194
🇷🇺Moscow, Russian Federation
S308.3.007 Site # 208
🇺🇦Simferopol, Ukraine
S308.3.007 Site # 200
🇺🇦Vinnytsya, Ukraine
S308.3.007 Site # 119
🇧🇷Salvador, Brazil
S308.3.007 Site # 110
🇧🇷São Paulo, Brazil
S308.3.007 Site # 153
🇨🇴Bogota, Colombia
S308.3.007 Site # 211
🇺🇸San Francisco, California, United States
S308.3.007 Site # 218
🇺🇸Gainsville, Florida, United States
S308.3.007 Site # 222
🇺🇸Durham, North Carolina, United States
S308.3.007 Site # 213
🇺🇸Tampa, Florida, United States
S308.3.007 Site # 220
🇺🇸LaJolla, California, United States
S308.3.007 Site # 214
🇺🇸Fort Lauderdale, Florida, United States
S308.3.007 Site # 224
🇺🇸Lexington, Kentucky, United States
S308.3.007 Site # 219
🇺🇸Augusta, Georgia, United States
S308.3.007 Site # 212
🇺🇸East Lansing, Michigan, United States
S308.3.007 Site # 100
🇦🇷Buenos Aires, Argentina
S308.3.007 Site # 101
🇦🇷Buenos Aires, Argentina
S308.3.007 Site # 107
🇦🇷Buenos Aires, Argentina
S308.3.007 Site # 103
🇦🇷Buenos Aires, Argentina
S308.3.007 Site # 105
🇦🇷Córdoba, Argentina
S308.3.007 Site # 108
🇦🇷Santa Fe, Argentina
S308.3.007 Site # 112
🇧🇷Campinas, Brazil
S308.3.007 Site # 113
🇧🇷Belo Horizonte, Brazil
S308.3.007 Site # 116
🇧🇷Marília, Brazil
S308.3.007 Site # 121
🇧🇬Sofia, Bulgaria
S308.3.007 Site # 133
🇨🇦Halifax, Canada
S308.3.007 Site # 130
🇨🇦Montreal, Canada
S308.3.007 Site # 138
🇨🇦Peterborough, Canada
S308.3.007 Site # 135
🇨🇦Sainte-Anne, Canada
S308.3.007 Site # 131
🇨🇦Windsor, Canada
S308.3.007 Site # 139
🇨🇦Toronto, Canada
S308.3.007 Site # 140
🇨🇱Santiago de Chile, Chile
S308.3.007 Site # 154
🇨🇴Bogota, Colombia
S308.3.007 Site # 171
🇱🇹Vilnius, Lithuania
S308.3.007 Site # 184
🇵🇪Bellavista Callao, Peru
S308.3.007 Site # 170
🇱🇹Vilnius, Lithuania
S308.3.007 Site # 181
🇵🇪Lima, Peru
S308.3.007 Site # 180
🇵🇪Lima, Peru
S308.3.007 Site # 193
🇷🇺Kazan, Russian Federation
S308.3.007 Site # 183
🇵🇪Lima, Peru
S308.3.007 Site # 191
🇷🇺Saint-Petersburg, Russian Federation
S308.3.007 Site # 192
🇷🇺Saint-Petersburg, Russian Federation
S308.3.007 Site # 198
🇷🇺Saint-Petersburg, Russian Federation
S308.3.007 Site # 102
🇦🇷Buenos Aires, Argentina