Advanced Stage Parkinson's Disease Clinical Trial
Official title:
An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
| Verified date | September 2010 |
| Source | Solvay Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 140 |
| Est. completion date | May 2009 |
| Est. primary completion date | May 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years and older |
| Eligibility | Inclusion Criteria Patients who have completed S308.3.002 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 S308.3.002 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Albania | S308.3.007 Site # 223 | Birmingham | |
| Argentina | S308.3.007 Site # 100 | Buenos Aires | |
| Argentina | S308.3.007 Site # 101 | Buenos Aires | |
| Argentina | S308.3.007 Site # 102 | Buenos Aires | |
| Argentina | S308.3.007 Site # 103 | Buenos Aires | |
| Argentina | S308.3.007 Site # 106 | Buenos Aires | |
| Argentina | S308.3.007 Site # 107 | Buenos Aires | |
| Argentina | S308.3.007 Site # 109 | Buenos Aires | |
| Argentina | S308.3.007 Site # 105 | Córdoba | |
| Argentina | S308.3.007 Site # 104 | Mar del Plata | |
| Argentina | S308.3.007 Site # 108 | Santa Fe | |
| Brazil | S308.3.007 Site # 114 | Alto da Glória | |
| Brazil | S308.3.007 Site # 113 | Belo Horizonte | |
| Brazil | S308.3.007 Site # 112 | Campinas | |
| Brazil | S308.3.007 Site # 116 | Marília | |
| Brazil | S308.3.007 Site # 111 | Porto Alegre | |
| Brazil | S308.3.007 Site # 118 | Porto Alegre | |
| Brazil | S308.3.007 Site # 117 | Ribeirão Preto | |
| Brazil | S308.3.007 Site # 119 | Salvador | |
| Brazil | S308.3.007 Site # 125 | Sao Paulo | |
| Brazil | S308.3.007 Site # 115 | Sâo Paulo | |
| Brazil | S308.3.007 Site # 110 | São Paulo | |
| Bulgaria | S308.3.007 Site # 123 | Plovdiv | |
| Bulgaria | S308.3.007 Site # 120 | Sofia | |
| Bulgaria | S308.3.007 Site # 121 | Sofia | |
| Bulgaria | S308.3.007 Site # 122 | Sofia | |
| Bulgaria | S308.3.007 Site # 124 | Sofia | |
| Canada | S308.3.007 Site # 136 | Calgary | |
| Canada | S308.3.007 Site # 137 | Greenfield Park | |
| Canada | S308.3.007 Site # 133 | Halifax | |
| Canada | S308.3.007 Site # 132 | Markham | |
| Canada | S308.3.007 Site # 130 | Montreal | |
| Canada | S308.3.007 Site # 134 | Ottava | |
| Canada | S308.3.007 Site # 138 | Peterborough | |
| Canada | S308.3.007 Site # 135 | Sainte-Anne | |
| Canada | S308.3.007 Site # 139 | Toronto | |
| Canada | S308.3.007 Site # 131 | Windsor | |
| Chile | S308.3.007 Site # 140 | Santiago de Chile | |
| Chile | S308.3.007 Site # 141 | Santiago de Chile | |
| Chile | S308.3.007 Site # 143 | Santiago de Chile | |
| Chile | S308.3.007 Site # 142 | Valdivia | |
| Colombia | S308.3.007 Site # 151 | Bogota | |
| Colombia | S308.3.007 Site # 152 | Bogota | |
| Colombia | S308.3.007 Site # 153 | Bogota | |
| Colombia | S308.3.007 Site # 154 | Bogota | |
| Colombia | S308.3.007 Site # 150 | Medellin | |
| Latvia | S308.3.007 Site # 160 | Riga | |
| Lithuania | S308.3.007 Site # 172 | Kaunas | |
| Lithuania | S308.3.007 Site # 170 | Vilnius | |
| Lithuania | S308.3.007 Site # 171 | Vilnius | |
| Peru | S308.3.007 Site # 184 | Bellavista Callao | |
| Peru | S308.3.007 Site # 180 | Lima | |
| Peru | S308.3.007 Site # 181 | Lima | |
| Peru | S308.3.007 Site # 182 | Lima | |
| Peru | S308.3.007 Site # 183 | Lima | |
| Russian Federation | S308.3.007 Site # 193 | Kazan | |
| Russian Federation | S308.3.007 Site # 190 | Moscow | |
| Russian Federation | S308.3.007 Site # 194 | Moscow | |
| Russian Federation | S308.3.007 Site # 197 | Moscow | |
| Russian Federation | S308.3.007 Site # 191 | Saint-Petersburg | |
| Russian Federation | S308.3.007 Site # 192 | Saint-Petersburg | |
| Russian Federation | S308.3.007 Site # 195 | Saint-Petersburg | |
| Russian Federation | S308.3.007 Site # 198 | Saint-Petersburg | |
| Russian Federation | S308.3.007 Site # 196 | Yaroslavl | |
| Ukraine | S308.3.007 Site # 204 | Dnepropetrovsk | |
| Ukraine | S308.3.007 Site # 206 | Kharkiv | |
| Ukraine | S308.3.007 Site # 201 | Kyiv | |
| Ukraine | S308.3.007 Site # 202 | Kyiv | |
| Ukraine | S308.3.007 Site # 205 | Lviv | |
| Ukraine | S308.3.007 Site # 203 | Poltava | |
| Ukraine | S308.3.007 Site # 208 | Simferopol | |
| Ukraine | S308.3.007 Site # 200 | Vinnytsya | |
| Ukraine | S308.3.007 Site # 207 | Zaporozhya | |
| United States | S308.3.007 Site # 219 | Augusta | Georgia |
| United States | S308.3.007 Site # 221 | Chicago | Illinois |
| United States | S308.3.007 Site # 222 | Durham | North Carolina |
| United States | S308.3.007 Site # 212 | East Lansing | Michigan |
| United States | S308.3.007 Site # 214 | Fort Lauderdale | Florida |
| United States | S308.3.007 Site # 218 | Gainsville | Florida |
| United States | S308.3.007 Site # 215 | Houston | Texas |
| United States | S308.3.007 Site # 216 | Kansas City | Kansas |
| United States | S308.3.007 Site # 220 | LaJolla | California |
| United States | S308.3.007 Site # 224 | Lexington | Kentucky |
| United States | S308.3.007 Site # 211 | San Francisco | California |
| United States | S308.3.007 Site # 217 | St. Louis | Missouri |
| United States | S308.3.007 Site # 213 | Tampa | Florida |
| United States | S308.3.007 Site # 210 | Tledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
United States, Albania, Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Latvia, Lithuania, Peru, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety: laboratory data, adverse events, vital signs, ECG | 36 weeks | Yes | |
| Secondary | On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline | 36 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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