Clinical trial NCT00269516: SLV308 for Treatment of Patients With Early Parkinson's Disease
Official title: A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Early Stage Parkinson's Disease
Keywords: Parkinson's disease
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 468
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease,
* Early stage of disease, Modified Hoehn \& Yahr up to stage III,
* UPDRS motor score (part III) 10 at baseline.

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
* Patients who have undergone surgery for the treatment of PD,
* Presence of dyskinesias,
* Motor fluctuations or loss of postural reflexes,
* Clinically significant abnormalities,
* Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
* Antipsychotic.

Primary outcomes:
measure: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
timeFrame: 6 months
Secondary outcomes:
measure: UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Site 284
state: Alabama
city: Little Rock
country: United States
facility: Site 274
state: Arkansas
city: Fountain Valley
country: United States
facility: Site 283
state: California
city: La Jolla
country: United States
facility: Site 277
state: California
city: San Francisco
country: United States
facility: Site 271
state: California
city: Ft Lauderdale
country: United States
facility: Site 279
state: Florida
city: Gainsville
country: United States
facility: Site 293
state: Florida
city: Port Charlotte
country: United States
facility: Site 282
state: Florida
city: Sunrise
country: United States
facility: Site 285
state: Florida
city: Tampa
country: United States
facility: Site 273
state: Florida
city: Chicago
country: United States
facility: Site 290
state: Illinois
city: Kansas City
country: United States
facility: Site 280
state: Kansas
city: Bingham Farms
country: United States
facility: Site 292
state: Michigan
city: Traverse City
country: United States
facility: Site 275
state: Michigan
city: St. Louis
country: United States
facility: Site 276
state: Missouri
city: St. Louis
country: United States
facility: Site 287
state: Missouri
city: Las Vegas
country: United States
facility: Site 278
state: Nevada
city: Rochester
country: United States
facility: Site 286
state: New York
city: Ashville
country: United States
facility: Site 288
state: North Carolina
city: Charlotte
country: United States
facility: Site 289
state: North Carolina
city: Toledo
country: United States
facility: Site 294
state: Ohio
city: Pittsburgh
country: United States
facility: Site 281
state: Pennsylvania
city: Warwick
country: United States
facility: Site 291
state: Rhode Island
city: Houston
country: United States
facility: Site 272
state: Texas
city: Buenos Aires
country: Argentina
facility: Site 201
city: Buenos Aires
country: Argentina
facility: Site 202
city: Buenos Aires
country: Argentina
facility: Site 204
city: Buenos Aires
country: Argentina
facility: Site 206
city: Capital Federal, CBA
country: Argentina
facility: Site 208
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Site 203
city: Ciudad de Buenos Aires
country: Argentina
facility: Site 207
city: Cordoba
country: Argentina
facility: Site 205
city: Brussels
country: Belgium
facility: Site 100
city: Genk
country: Belgium
facility: Site 101
city: Wilrijk
country: Belgium
facility: Site 102
city: Plovdiv
country: Bulgaria
facility: Site 107
city: Sofia
country: Bulgaria
facility: Site 103
city: Sofia
country: Bulgaria
facility: Site 104
city: Sofia
country: Bulgaria
facility: Site 105
city: Sofia
country: Bulgaria
facility: Site 106
city: Barrie
country: Canada
facility: Site 268
city: Calgary
country: Canada
facility: Site 260
city: Greenfield Park
country: Canada
facility: Site 264
city: Markham
country: Canada
facility: Site 263
city: Ottawa
country: Canada
facility: Site 261
city: Ottawa
country: Canada
facility: Site 266
city: Quebec
country: Canada
facility: Site 262
city: Quebec
country: Canada
facility: Site 265
city: Saskatoon
country: Canada
facility: Site 269
city: Toronto
country: Canada
facility: Site 267
city: Providencia
country: Chile
facility: Site 213
city: San Miguel
country: Chile
facility: Site 211
city: Santiago de Chile
country: Chile
facility: Site 210
city: Valdivia
country: Chile
facility: Site 212
city: Bogota
country: Colombia
facility: Site 221
city: Bogota
country: Colombia
facility: Site 223
city: Bogota
country: Colombia
facility: Site 224
city: Cali
country: Colombia
facility: Site 222
city: Medellin
country: Colombia
facility: Site 220
city: Rijeka
country: Croatia
facility: Site 111
city: Split
country: Croatia
facility: Site 112
city: Zagreb
country: Croatia
facility: Site 110
city: Zagreb
country: Croatia
facility: Site 113
city: Zagreb
country: Croatia
facility: Site 114
city: Kuopio
country: Finland
facility: Site 123
city: Lappeenranta
country: Finland
facility: Site 122
city: Oulun yliopisto
country: Finland
facility: Site 120
city: Tampere
country: Finland
facility: Site 121
city: Turku
country: Finland
facility: Site 124
city: Bangalore
country: India
facility: Site 196
city: Hyderabaad
country: India
facility: Site 194
city: Mumbai
country: India
facility: Site 193
city: Mumbai
country: India
facility: Site 195
city: New Delhi
country: India
facility: Site 199
city: Thiruvananthapuram
country: India
facility: Site 198
city: Visakhapatnam
country: India
facility: Site 197
city: Haifa
country: Israel
facility: Site 131
city: Petach-Tikva
country: Israel
facility: Site 132
city: Ramat-Gan
country: Israel
facility: Site 133
city: Tel Aviv
country: Israel
facility: Site 130
city: Aguascalientes
country: Mexico
facility: Site 232
city: Guadalajara - Jalisco
country: Mexico
facility: Site 230
city: Monterrey N.L.
country: Mexico
facility: Site 231
city: Tlalpan
country: Mexico
facility: Site 233
city: Christchurch
country: New Zealand
facility: Site 191
city: Wellington South
country: New Zealand
facility: Site 190
city: Barrios Altos-Lima
country: Peru
facility: Site 244
city: La Victoria-Lima
country: Peru
facility: Site 241
city: Lima
country: Peru
facility: Site 240
city: San Isidro-Lima
country: Peru
facility: Site 243
city: Surco-Lima
country: Peru
facility: Site 242
city: Brasov
country: Romania
facility: Site 143
city: Bucuresti
country: Romania
facility: Site 140
city: Craiova
country: Romania
facility: Site 141
city: Mures
country: Romania
facility: Site 142
city: Kazan
country: Russian Federation
facility: Site 158
city: Moscow
country: Russian Federation
facility: Site 150
city: Moscow
country: Russian Federation
facility: Site 151
city: Moscow
country: Russian Federation
facility: Site 154
city: Moscow
country: Russian Federation
facility: Site 156
city: Smolensk
country: Russian Federation
facility: Site 155
city: St Petersburg
country: Russian Federation
facility: Site 152
city: St Petersburg
country: Russian Federation
facility: Site 157
city: St Petersburg
country: Russian Federation
facility: Site 159
city: Yaroslav
country: Russian Federation
facility: Site 153
city: Belgrade
country: Serbia
facility: Site 160
city: Belgrade
country: Serbia
facility: Site 161
city: Belgrade
country: Serbia
facility: Site 162
city: Nis
country: Serbia
facility: Site 163
city: Bratislava
country: Slovakia
facility: Site 170
city: Bratislava
country: Slovakia
facility: Site 171
city: Levice
country: Slovakia
facility: Site 174
city: Nitra
country: Slovakia
facility: Site 173
city: Zilina
country: Slovakia
facility: Site 172
city: Cape Town
country: South Africa
facility: Site 250
city: Cape Town
country: South Africa
facility: Site 252
city: Durban
country: South Africa
facility: Site 251
city: Gauteng
country: South Africa
facility: Site 253
city: Pretoria
country: South Africa
facility: Site 254
city: Goteborg
country: Sweden
facility: Site 127
city: Norrkoping
country: Sweden
facility: Site 126
city: Stockholm
country: Sweden
facility: Site 125
city: Kharkiv
country: Ukraine
facility: Site 180
city: Kharkiv
country: Ukraine
facility: Site 183
city: Kyiv
country: Ukraine
facility: Site 181
city: Kyiv
country: Ukraine
facility: Site 182
city: Lviv
country: Ukraine
facility: Site 185
city: Vinnytsya
country: Ukraine
facility: Site 184
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3.