SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations
- Conditions
- Advanced Stage Parkinson's Disease
- Interventions
- Drug: Levodopa (Pardoprunox)Drug: Placebo Comparator
- Registration Number
- NCT00406588
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 295
- Diagnosis of idiopathic Parkinson's Disease,
- advance stage of disease,
- Modified Hoehn & Yahr stage II-IV,
- presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization
- 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,
- Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,
- Previous surgery for the treatment of PD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Levodopa (Pardoprunox) - 2 Placebo Comparator -
- Primary Outcome Measures
Name Time Method Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries. 12 weeks
- Secondary Outcome Measures
Name Time Method Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39 12 weeks
Trial Locations
- Locations (87)
Site 220
🇺🇸LaJolla, California, United States
Site 223
🇺🇸Birmingham, Alabama, United States
Site 211
🇺🇸San Francisco, California, United States
Site 214
🇺🇸Fort Lauderdale, Florida, United States
Site 218
🇺🇸Gainsville, Florida, United States
Site 213
🇺🇸Tampa, Florida, United States
Site 212
🇺🇸East Lansing, Michigan, United States
Site 219
🇺🇸Augusta, Georgia, United States
Site 221
🇺🇸Chicago, Illinois, United States
Site 224
🇺🇸Lexington, Kentucky, United States
Site 216
🇺🇸Kansas City, Kansas, United States
Site 217
🇺🇸St. Louis, Missouri, United States
Site 222
🇺🇸Durham, North Carolina, United States
Site 210
🇺🇸Toledo, Ohio, United States
Site 215
🇺🇸Houston, Texas, United States
Site 103
🇦🇷Buenos Aires, Argentina
Site 102
🇦🇷Buenos Aires, Argentina
Site 101
🇦🇷Buenos Aires, Argentina
Site 100
🇦🇷Buenos Aires, Argentina
Site 107
🇦🇷Buenos Aires, Argentina
Site 106
🇦🇷Buenos Aires, Argentina
Site 109
🇦🇷Buenos Aires, Argentina
Site 104
🇦🇷Mar del Plata, Argentina
Site 105
🇦🇷Cordoba, Argentina
Site 108
🇦🇷Santa Fe, Argentina
Site 114
🇧🇷Alto da Gloria, Brazil
Site 113
🇧🇷Belo Horizonte, Brazil
Site 112
🇧🇷Campinas, Brazil
Site 116
🇧🇷Marilia, Brazil
Site 111
🇧🇷Porto Alegre, Brazil
Site 117
🇧🇷Ribeirao Preto, Brazil
Site 118
🇧🇷Porto Alegre, Brazil
Site 119
🇧🇷Salvador, Brazil
Site 115
🇧🇷Sao Paulo, Brazil
Site 110
🇧🇷Sao Paulo, Brazil
Site 125
🇧🇷Sao Paulo, Brazil
Site 123
🇧🇬Plovdiv, Bulgaria
Site 120
🇧🇬Sofia, Bulgaria
Site 121
🇧🇬Sofia, Bulgaria
Site 122
🇧🇬Sofia, Bulgaria
Site 133
🇨🇦Halifax, Canada
Site 124
🇧🇬Sofia, Bulgaria
Site 136
🇨🇦Calgary, Canada
Site 137
🇨🇦Greenfield Park, Canada
Site 132
🇨🇦Markham, Canada
Site 134
🇨🇦Ottawa, Canada
Site 139
🇨🇦Toronto, Canada
Site 138
🇨🇦Peterborough, Canada
Site 130
🇨🇦Montreal, Canada
Site 135
🇨🇦Sainte-Anne, Canada
Site 140
🇨🇱Santiago de Chile, Chile
Site 131
🇨🇦Windsor, Canada
Site 141
🇨🇱Santiago de Chile, Chile
Site 143
🇨🇱Santiago de Chile, Chile
Site 151
🇨🇴Bogota, Colombia
Site 154
🇨🇴Bogota, Colombia
Site 152
🇨🇴Bogota, Colombia
Site 150
🇨🇴Medellin, Colombia
Site 184
🇵🇪Bellavista Callao, Peru
Site 193
🇷🇺Kazan, Russian Federation
Site 190
🇷🇺Moscow, Russian Federation
Site 194
🇷🇺Moscow, Russian Federation
Site 191
🇷🇺Saint-Petersburg, Russian Federation
Site 197
🇷🇺Moscow, Russian Federation
Site 198
🇷🇺Saint Petersburg, Russian Federation
Site 192
🇷🇺Saint-Petersburg, Russian Federation
Site 204
🇺🇦Dnepropetrovsk, Ukraine
Site 195
🇷🇺Saint-Petersburg, Russian Federation
Site 196
🇷🇺Yaroslavl, Russian Federation
Site 206
🇺🇦Kharkiv, Ukraine
Site 202
🇺🇦Kyiv, Ukraine
Site 205
🇺🇦Lviv, Ukraine
Site 208
🇺🇦Simferopol, Ukraine
Site 172
🇱🇹Kaunas, Lithuania
Site 170
🇱🇹Vilnius, Lithuania
Site 171
🇱🇹Vilnius, Lithuania
Site 180
🇵🇪Lima, Peru
Site 181
🇵🇪Lima, Peru
Site 182
🇵🇪Lima, Peru
Site 183
🇵🇪Lima, Peru
Site 207
🇺🇦Zaporizhya, Ukraine
Site 153
🇨🇴Bogota, Colombia
Site 142
🇨🇱Valdivia, Chile
Site 201
🇺🇦Kyiv, Ukraine
Site 203
🇺🇦Poltava, Ukraine
Site 200
🇺🇦Vinnitsa, Ukraine
Site 160
🇱🇻Riga, Latvia