An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
2 other identifiers
interventional
224
20 countries
127
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2007
127 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2006
CompletedFirst Posted
Study publicly available on registry
June 2, 2006
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJanuary 26, 2009
January 1, 2009
1.4 years
June 1, 2006
January 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety: laboratory data, adverse events, vital signs, ECG
24 weeks
Secondary Outcomes (1)
UPDRS parts 1, 2 and 3, CGI-severity, CGI-improvement, PDQ-39 total score: all change from baseline
24 weeks
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients who have completed S308.3.001 trial
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (130)
Site 284
Huntsville, Alabama, United States
Site 274
Little Rock, Arkansas, United States
Site 283
Fountain Valley, California, United States
Site 277
La Jolla, California, United States
Site 271
San Francisco, California, United States
Site 279
Fort Lauderdale, Florida, United States
Site 293
Gainsville, Florida, United States
Site 282
Port Charlotte, Florida, United States
Site 285
Sunrise, Florida, United States
Site 273
Tampa, Florida, United States
Site 290
Chicago, Illinois, United States
Site 280
Kansas City, Kansas, United States
Site 292
Bingham Farms, Michigan, United States
Site 275
Traverse City, Michigan, United States
Site 276
St Louis, Missouri, United States
Site 287
St Louis, Missouri, United States
Site 278
Las Vegas, Nevada, United States
Site 286
Rochester, New York, United States
Site 288
Ashville, North Carolina, United States
Site 289
Charlotte, North Carolina, United States
Site 294
Toledo, Ohio, United States
Site 281
Pittsburgh, Pennsylvania, United States
Site 291
Warwick, Rhode Island, United States
Site 272
Houston, Texas, United States
Site 270
Bennington, Vermont, United States
Site 200
Buenos Aires, Argentina
Site 201
Buenos Aires, Argentina
Site 202
Buenos Aires, Argentina
Site 203
Buenos Aires, Argentina
Site 204
Buenos Aires, Argentina
Site 206
Buenos Aires, Argentina
Site 208
Capital Federal, CBA, Argentina
Site 207
Ciudad de Buenos Aires, Argentina
Site 205
Córdoba, Argentina
Site 100
Brussels, Belgium
Site 101
Genk, Belgium
Site 102
Wilrijk, Belgium
Site 107
Plovdiv, Bulgaria
Site 103
Sofia, Bulgaria
Site 104
Sofia, Bulgaria
Site 105
Sofia, Bulgaria
Site 106
Sofia, Bulgaria
Site 268
Barrie, Canada
Site 260
Calgary, Canada
Site 264
Greenfield Park, Canada
Site 263
Markham, Canada
Site 261
Ottawa, Canada
Site 266
Ottawa, Canada
Site 262
Québec, Canada
Site 265
Québec, Canada
Site 269
Saskatoon, Canada
Site 267
Toronto, Canada
Site 213
Providencia, Chile
Site 211
San Miguel, Chile
Site 210
Santiago, Chile
Site 212
Valdivia, Chile
Site 221
Bogotá, Colombia
Site 223
Bogotá, Colombia
Site 224
Bogotá, Colombia
Site 222
Cali, Colombia
Site 220
Medellín, Colombia
Site 111
Rijeka, Croatia
Site 112
Split, Croatia
Site 110
Zagreb, Croatia
Site 113
Zagreb, Croatia
Site 114
Zagreb, Croatia
Site 123
Kuopio, Finland
Site 122
Lappeenranta, Finland
Site 120
Oulun Yliopisto, Finland
Site 121
Tampere, Finland
Site 124
Turku, Finland
Site 196
Bangalore, India
Site 194
Hyderabaad, India
Site 193
Mumbai, India
Site 195
Mumbai, India
Site 199
New Delhi, India
Site 198
Thiruvananthapuram, India
Site 197
Visakhapatnam, India
Site 131
Haifa, Israel
Site 132
Petah Tikva, Israel
Site 133
Ramat Gan, Israel
Site 130
Tel Aviv, Israel
Site 232
Aguascalientes, Mexico
Site 230
Guadalajara - Jalisco, Mexico
Site 231
Monterrey N.L., Mexico
Site 233
Tlalpan, Mexico
Site 191
Christchurch, New Zealand
Site 190
Wellington South, New Zealand
Site 244
Barrios Altos-Lima, Peru
Site 241
La Victoria-Lima, Peru
Site 240
Lima, Peru
Site 243
San Isidro-Lima, Peru
Site 242
Surco-Lima, Peru
Site 143
Brasov, Romania
Site 140
Bucharest, Romania
Site 141
Craiova, Romania
Site 142
Mures, Romania
Site 158
Kazan', Russia
Site 150
Moscow, Russia
Site 151
Moscow, Russia
Site 154
Moscow, Russia
Site 156
Moscow, Russia
Site 152
Saint Petersburg, Russia
Site 157
Saint Petersburg, Russia
Site 159
Saint Petersburg, Russia
Site 155
Smolensk, Russia
Site 153
Yaroslav, Russia
Site 160
Belgrade, Serbia
Site 161
Belgrade, Serbia
Site 162
Belgrade, Serbia
Site 163
Niš, Serbia
Site 170
Bratislava, Slovakia
Site 171
Bratislava, Slovakia
Site 174
Levice, Slovakia
Site 173
Nitra, Slovakia
Site 172
Žilina, Slovakia
Site 250
Cape Town, South Africa
Site 252
Cape Town, South Africa
Site 251
Durban, South Africa
Site 253
Gauteng, South Africa
Site 254
Pretoria, South Africa
Site 127
Gothenburg, Sweden
Site 126
Norrköping, Sweden
Site 125
Stockholm, Sweden
Site 180
Kharkiv, Ukraine
Site 183
Kharkiv, Ukraine
Site 181
Kyiv, Ukraine
Site 182
Kyiv, Ukraine
Site 185
Lviv, Ukraine
Site 184
Vinnitsa, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 1, 2006
First Posted
June 2, 2006
Study Start
February 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
January 26, 2009
Record last verified: 2009-01