An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
Sponsor
Solvay Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00332917
Collaborator
(none)
224
130
1
17
1.7
0.1
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
224 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
Study Start Date
:
Feb 1, 2007
Actual Primary Completion Date
:
Jul 1, 2008
Actual Study Completion Date
:
Jul 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: Pardoprunox
12-42 mg
|
Outcome Measures
Primary Outcome Measures
- Safety: laboratory data, adverse events, vital signs, ECG [24 weeks]
Secondary Outcome Measures
- UPDRS parts 1, 2 and 3, CGI-severity, CGI-improvement, PDQ-39 total score: all change from baseline [24 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 284 | Huntsville | Alabama | United States | |
| 2 | Site 274 | Little Rock | Arkansas | United States | |
| 3 | Site 283 | Fountain Valley | California | United States | |
| 4 | Site 277 | La Jolla | California | United States | |
| 5 | Site 271 | San Francisco | California | United States | |
| 6 | Site 279 | Ft Lauderdale | Florida | United States | |
| 7 | Site 293 | Gainsville | Florida | United States | |
| 8 | Site 282 | Port Charlotte | Florida | United States | |
| 9 | Site 285 | Sunrise | Florida | United States | |
| 10 | Site 273 | Tampa | Florida | United States | |
| 11 | Site 290 | Chicago | Illinois | United States | |
| 12 | Site 280 | Kansas City | Kansas | United States | |
| 13 | Site 292 | Bingham Farms | Michigan | United States | |
| 14 | Site 275 | Traverse City | Michigan | United States | |
| 15 | Site 276 | St. Louis | Missouri | United States | |
| 16 | Site 287 | St. Louis | Missouri | United States | |
| 17 | Site 278 | Las Vegas | Nevada | United States | |
| 18 | Site 286 | Rochester | New York | United States | |
| 19 | Site 288 | Ashville | North Carolina | United States | |
| 20 | Site 289 | Charlotte | North Carolina | United States | |
| 21 | Site 294 | Toledo | Ohio | United States | |
| 22 | Site 281 | Pittsburgh | Pennsylvania | United States | |
| 23 | Site 291 | Warwick | Rhode Island | United States | |
| 24 | Site 272 | Houston | Texas | United States | |
| 25 | Site 270 | Bennington | Vermont | United States | |
| 26 | Site 200 | Buenos Aires | Argentina | ||
| 27 | Site 201 | Buenos Aires | Argentina | ||
| 28 | Site 202 | Buenos Aires | Argentina | ||
| 29 | Site 204 | Buenos Aires | Argentina | ||
| 30 | Site 206 | Buenos Aires | Argentina | ||
| 31 | Site 208 | Capital Federal, CBA | Argentina | ||
| 32 | Site 203 | Ciudad Autonoma de Buenos Aires | Argentina | ||
| 33 | Site 207 | Ciudad de Buenos Aires | Argentina | ||
| 34 | Site 205 | Cordoba | Argentina | ||
| 35 | Site 100 | Brussels | Belgium | ||
| 36 | Site 101 | Genk | Belgium | ||
| 37 | Site 102 | Wilrijk | Belgium | ||
| 38 | Site 107 | Plovdiv | Bulgaria | ||
| 39 | Site 103 | Sofia | Bulgaria | ||
| 40 | Site 104 | Sofia | Bulgaria | ||
| 41 | Site 105 | Sofia | Bulgaria | ||
| 42 | Site 106 | Sofia | Bulgaria | ||
| 43 | Site 268 | Barrie | Canada | ||
| 44 | Site 260 | Calgary | Canada | ||
| 45 | Site 264 | Greenfield Park | Canada | ||
| 46 | Site 263 | Markham | Canada | ||
| 47 | Site 261 | Ottawa | Canada | ||
| 48 | Site 266 | Ottawa | Canada | ||
| 49 | Site 262 | Quebec | Canada | ||
| 50 | Site 265 | Quebec | Canada | ||
| 51 | Site 269 | Saskatoon | Canada | ||
| 52 | Site 267 | Toronto | Canada | ||
| 53 | Site 213 | Providencia | Chile | ||
| 54 | Site 211 | San Miguel | Chile | ||
| 55 | Site 210 | Santiago de Chile | Chile | ||
| 56 | Site 212 | Valdivia | Chile | ||
| 57 | Site 221 | Bogota | Colombia | ||
| 58 | Site 223 | Bogota | Colombia | ||
| 59 | Site 224 | Bogota | Colombia | ||
| 60 | Site 222 | Cali | Colombia | ||
| 61 | Site 220 | Medellin | Colombia | ||
| 62 | Site 111 | Rijeka | Croatia | ||
| 63 | Site 112 | Split | Croatia | ||
| 64 | Site 110 | Zagreb | Croatia | ||
| 65 | Site 113 | Zagreb | Croatia | ||
| 66 | Site 114 | Zagreb | Croatia | ||
| 67 | Site 123 | Kuopio | Finland | ||
| 68 | Site 122 | Lappeenranta | Finland | ||
| 69 | Site 120 | Oulun yliopisto | Finland | ||
| 70 | Site 121 | Tampere | Finland | ||
| 71 | Site 124 | Turku | Finland | ||
| 72 | Site 196 | Bangalore | India | ||
| 73 | Site 194 | Hyderabaad | India | ||
| 74 | Site 193 | Mumbai | India | ||
| 75 | Site 195 | Mumbai | India | ||
| 76 | Site 199 | New Delhi | India | ||
| 77 | Site 198 | Thiruvananthapuram | India | ||
| 78 | Site 197 | Visakhapatnam | India | ||
| 79 | Site 131 | Haifa | Israel | ||
| 80 | Site 132 | Petach-Tikva | Israel | ||
| 81 | Site 133 | Ramat-Gan | Israel | ||
| 82 | Site 130 | Tel Aviv | Israel | ||
| 83 | Site 232 | Aguascalientes | Mexico | ||
| 84 | Site 230 | Guadalajara - Jalisco | Mexico | ||
| 85 | Site 231 | Monterrey N.L. | Mexico | ||
| 86 | Site 233 | Tlalpan | Mexico | ||
| 87 | Site 191 | Christchurch | New Zealand | ||
| 88 | Site 190 | Wellington South | New Zealand | ||
| 89 | Site 244 | Barrios Altos-Lima | Peru | ||
| 90 | Site 241 | La Victoria-Lima | Peru | ||
| 91 | Site 240 | Lima | Peru | ||
| 92 | Site 243 | San Isidro-Lima | Peru | ||
| 93 | Site 242 | Surco-Lima | Peru | ||
| 94 | Site 143 | Brasov | Romania | ||
| 95 | Site 140 | Bucuresti | Romania | ||
| 96 | Site 141 | Craiova | Romania | ||
| 97 | Site 142 | Mures | Romania | ||
| 98 | Site 158 | Kazan | Russian Federation | ||
| 99 | Site 150 | Moscow | Russian Federation | ||
| 100 | Site 151 | Moscow | Russian Federation | ||
| 101 | Site 154 | Moscow | Russian Federation | ||
| 102 | Site 156 | Moscow | Russian Federation | ||
| 103 | Site 155 | Smolensk | Russian Federation | ||
| 104 | Site 159 | St Petersburg | Russian Federation | ||
| 105 | Site 152 | St. Petersburg | Russian Federation | ||
| 106 | Site 157 | St. Petersburg | Russian Federation | ||
| 107 | Site 153 | Yaroslav | Russian Federation | ||
| 108 | Site 160 | Belgrade | Serbia | ||
| 109 | Site 161 | Belgrade | Serbia | ||
| 110 | Site 162 | Belgrade | Serbia | ||
| 111 | Site 163 | Nis | Serbia | ||
| 112 | Site 170 | Bratislava | Slovakia | ||
| 113 | Site 171 | Bratislava | Slovakia | ||
| 114 | Site 174 | Levice | Slovakia | ||
| 115 | Site 173 | Nitra | Slovakia | ||
| 116 | Site 172 | Zilina | Slovakia | ||
| 117 | Site 250 | Cape Town | South Africa | ||
| 118 | Site 252 | Cape Town | South Africa | ||
| 119 | Site 251 | Durban | South Africa | ||
| 120 | Site 253 | Gauteng | South Africa | ||
| 121 | Site 254 | Pretoria | South Africa | ||
| 122 | Site 127 | Goteborg | Sweden | ||
| 123 | Site 126 | Norrkoping | Sweden | ||
| 124 | Site 125 | Stockholm | Sweden | ||
| 125 | Site 180 | Kharkiv | Ukraine | ||
| 126 | Site 183 | Kharkiv | Ukraine | ||
| 127 | Site 181 | Kyiv | Ukraine | ||
| 128 | Site 182 | Kyiv | Ukraine | ||
| 129 | Site 185 | Lviv | Ukraine | ||
| 130 | Site 184 | Vinnitsa | Ukraine |
Sponsors and Collaborators
- Solvay Pharmaceuticals
Investigators
- Study Director: Global Clinical Director Solvay, Solvay Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00332917
Other Study ID Numbers:
- S308.3.006
- 2006-000858-45
First Posted:
Jun 2, 2006
Last Update Posted:
Jan 26, 2009
Last Verified:
Jan 1, 2009