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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005182-20 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa (Pardoprunox) | Drug | 12-42mg |
| |
| Placebo Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 223 | Birmingham | Alabama | United States | |||
| Site 220 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22316635 | Derived | Rascol O, Bronzova J, Hauser RA, Lang AE, Sampaio C, Theeuwes A, van de Witte SV. Pardoprunox as adjunct therapy to levodopa in patients with Parkinson's disease experiencing motor fluctuations: results of a double-blind, randomized, placebo-controlled, trial. Parkinsonism Relat Disord. 2012 May;18(4):370-6. doi: 10.1016/j.parkreldis.2011.12.006. Epub 2012 Feb 7. |
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| Drug |
Placebo |
|
| La Jolla |
| California |
| 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 219 | Augusta | Georgia | United States |
| Site 221 | Chicago | Illinois | United States |
| Site 216 | Kansas City | Kansas | United States |
| Site 224 | Lexington | Kentucky | United States |
| Site 212 | East Lansing | Michigan | 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 100 | Buenos Aires | Argentina |
| Site 101 | Buenos Aires | Argentina |
| Site 102 | Buenos Aires | Argentina |
| Site 103 | Buenos Aires | Argentina |
| Site 106 | Buenos Aires | Argentina |
| Site 107 | Buenos Aires | Argentina |
| Site 109 | Buenos Aires | Argentina |
| Site 105 | Córdoba | Argentina |
| Site 104 | Mar del Plata | Argentina |
| Site 108 | Santa Fe | Argentina |
| Site 114 | Alto da Glória | Brazil |
| Site 113 | Belo Horizonte | Brazil |
| Site 112 | Campinas | Brazil |
| Site 116 | Marília | Brazil |
| Site 111 | Porto Alegre | Brazil |
| Site 118 | Porto Alegre | Brazil |
| Site 117 | Ribeirão Preto | Brazil |
| Site 119 | Salvador | Brazil |
| Site 110 | São Paulo | Brazil |
| Site 115 | São Paulo | Brazil |
| Site 125 | São Paulo | Brazil |
| Site 123 | Plovdiv | Bulgaria |
| Site 120 | Sofia | Bulgaria |
| Site 121 | Sofia | Bulgaria |
| Site 122 | Sofia | Bulgaria |
| Site 124 | Sofia | Bulgaria |
| Site 136 | Calgary | Canada |
| Site 137 | Greenfield Park | Canada |
| Site 133 | Halifax | Canada |
| Site 132 | Markham | Canada |
| Site 130 | Montreal | Canada |
| Site 134 | Ottawa | Canada |
| Site 138 | Peterborough | Canada |
| Site 135 | Sainte-Anne | Canada |
| Site 139 | Toronto | Canada |
| Site 131 | Windsor | Canada |
| Site 140 | Santiago | Chile |
| Site 141 | Santiago | Chile |
| Site 143 | Santiago | Chile |
| Site 142 | Valdivia | Chile |
| Site 151 | Bogotá | Colombia |
| Site 152 | Bogotá | Colombia |
| Site 153 | Bogotá | Colombia |
| Site 154 | Bogotá | Colombia |
| Site 150 | Medellín | Colombia |
| Site 160 | Riga | Latvia |
| Site 172 | Kaunas | Lithuania |
| Site 170 | Vilnius | Lithuania |
| Site 171 | Vilnius | Lithuania |
| Site 184 | Bellavista Callao | Peru |
| Site 180 | Lima | Peru |
| Site 181 | Lima | Peru |
| Site 182 | Lima | Peru |
| Site 183 | Lima | Peru |
| Site 193 | Kazan' | Russia |
| Site 190 | Moscow | Russia |
| Site 194 | Moscow | Russia |
| Site 197 | Moscow | Russia |
| Site 191 | Saint Petersburg | Russia |
| Site 192 | Saint Petersburg | Russia |
| Site 195 | Saint Petersburg | Russia |
| Site 198 | Saint Petersburg | Russia |
| Site 196 | Yaroslavl | Russia |
| Site 204 | Dnipro | Ukraine |
| Site 206 | Kharkiv | Ukraine |
| Site 201 | Kyiv | Ukraine |
| Site 202 | Kyiv | Ukraine |
| Site 205 | Lviv | Ukraine |
| Site 203 | Poltava | Ukraine |
| Site 208 | Simferopol | Ukraine |
| Site 200 | Vinnitsa | Ukraine |
| Site 207 | Zaporizhya | Ukraine |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| C480679 | pardoprunox |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
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