Advanced Stage Parkinson's Disease Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
| Verified date | July 2008 |
| 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, 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.
| Status | Completed |
| Enrollment | 295 |
| Est. completion date | May 2008 |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - '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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 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 | Cordoba | |
| Argentina | Site 104 | Mar del Plata | |
| Argentina | Site 108 | Santa Fe | |
| Brazil | 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 118 | Porto Alegre | |
| Brazil | Site 117 | Ribeirao Preto | |
| Brazil | Site 119 | Salvador | |
| Brazil | Site 110 | Sao Paulo | |
| Brazil | Site 115 | Sao Paulo | |
| Brazil | Site 125 | Sao Paulo | |
| Bulgaria | Site 123 | Plovdiv | |
| Bulgaria | Site 120 | Sofia | |
| Bulgaria | Site 121 | Sofia | |
| Bulgaria | Site 122 | Sofia | |
| Bulgaria | Site 124 | Sofia | |
| Canada | 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 | |
| Chile | Site 140 | Santiago de Chile | |
| Chile | Site 141 | Santiago de Chile | |
| Chile | Site 143 | Santiago de Chile | |
| Chile | Site 142 | Valdivia | |
| Colombia | Site 151 | Bogota | |
| Colombia | Site 152 | Bogota | |
| Colombia | Site 153 | Bogota | |
| Colombia | Site 154 | Bogota | |
| Colombia | Site 150 | Medellin | |
| Latvia | Site 160 | Riga | |
| Lithuania | Site 172 | Kaunas | |
| Lithuania | Site 170 | Vilnius | |
| Lithuania | Site 171 | Vilnius | |
| Peru | Site 184 | Bellavista Callao | |
| Peru | Site 180 | Lima | |
| Peru | Site 181 | Lima | |
| Peru | Site 182 | Lima | |
| Peru | Site 183 | Lima | |
| Russian Federation | Site 193 | Kazan | |
| Russian Federation | Site 190 | Moscow | |
| Russian Federation | Site 194 | Moscow | |
| Russian Federation | Site 197 | Moscow | |
| Russian Federation | Site 198 | Saint Petersburg | |
| Russian Federation | Site 191 | Saint-Petersburg | |
| Russian Federation | Site 192 | Saint-Petersburg | |
| Russian Federation | Site 195 | Saint-Petersburg | |
| Russian Federation | Site 196 | Yaroslavl | |
| Ukraine | Site 204 | Dnepropetrovsk | |
| 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 | |
| United States | Site 219 | Augusta | Georgia |
| United States | Site 223 | Birmingham | Alabama |
| United States | Site 221 | Chicago | Illinois |
| United States | Site 222 | Durham | North Carolina |
| United States | Site 212 | East Lansing | Michigan |
| United States | Site 214 | Fort Lauderdale | Florida |
| United States | Site 218 | Gainsville | Florida |
| United States | Site 215 | Houston | Texas |
| United States | Site 216 | Kansas City | Kansas |
| United States | Site 220 | LaJolla | California |
| United States | Site 224 | Lexington | Kentucky |
| United States | Site 211 | San Francisco | California |
| United States | Site 217 | St. Louis | Missouri |
| United States | Site 213 | Tampa | Florida |
| United States | Site 210 | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
United States, Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Latvia, Lithuania, Peru, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39 | 12 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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Phase 3 | |
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