An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332917
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : January 26, 2009
Information provided by:
Solvay Pharmaceuticals

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
Early Stage Parkinson's Disease Drug: Pardoprunox Phase 3

Study Type : Interventional  (Clinical Trial)
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 : February 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Pardoprunox
12-42 mg

Primary Outcome Measures :
  1. Safety: laboratory data, adverse events, vital signs, ECG [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. UPDRS parts 1, 2 and 3, CGI-severity, CGI-improvement, PDQ-39 total score: all change from baseline [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00332917

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United States, Alabama
Site 284
Huntsville, Alabama, United States
United States, Arkansas
Site 274
Little Rock, Arkansas, United States
United States, California
Site 283
Fountain Valley, California, United States
Site 277
La Jolla, California, United States
Site 271
San Francisco, California, United States
United States, Florida
Site 279
Ft Lauderdale, Florida, United States
Site 293
Gainsville, Florida, United States
Site 282
Port Charlotte, Florida, United States
Site 285
Sunrise, Florida, United States
Site 273
Tampa, Florida, United States
United States, Illinois
Site 290
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United States, Kansas
Site 280
Kansas City, Kansas, United States
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Site 292
Bingham Farms, Michigan, United States
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St. Louis, Missouri, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Bennington, Vermont, United States
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Site 204
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Site 206
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Site 100
Brussels, Belgium
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Site 102
Wilrijk, Belgium
Site 107
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Site 103
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Site 104
Sofia, Bulgaria
Site 105
Sofia, Bulgaria
Site 106
Sofia, Bulgaria
Site 268
Barrie, Canada
Site 260
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Site 264
Greenfield Park, Canada
Site 263
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Site 266
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Site 262
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Site 265
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Site 269
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Toronto, Canada
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Site 221
Bogota, Colombia
Site 223
Bogota, Colombia
Site 224
Bogota, Colombia
Site 222
Cali, Colombia
Site 220
Medellin, Colombia
Site 111
Rijeka, Croatia
Site 112
Split, Croatia
Site 110
Zagreb, Croatia
Site 113
Zagreb, Croatia
Site 114
Zagreb, Croatia
Site 123
Kuopio, Finland
Site 122
Lappeenranta, Finland
Site 120
Oulun yliopisto, Finland
Site 121
Tampere, Finland
Site 124
Turku, Finland
Site 196
Bangalore, India
Site 194
Hyderabaad, India
Site 193
Mumbai, India
Site 195
Mumbai, India
Site 199
New Delhi, India
Site 198
Thiruvananthapuram, India
Site 197
Visakhapatnam, India
Site 131
Haifa, Israel
Site 132
Petach-Tikva, Israel
Site 133
Ramat-Gan, Israel
Site 130
Tel Aviv, Israel
Site 232
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Site 230
Guadalajara - Jalisco, Mexico
Site 231
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New Zealand
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Wellington South, New Zealand
Site 244
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Site 241
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Site 240
Lima, Peru
Site 243
San Isidro-Lima, Peru
Site 242
Surco-Lima, Peru
Site 143
Brasov, Romania
Site 140
Bucuresti, Romania
Site 141
Craiova, Romania
Site 142
Mures, Romania
Russian Federation
Site 158
Kazan, Russian Federation
Site 150
Moscow, Russian Federation
Site 151
Moscow, Russian Federation
Site 154
Moscow, Russian Federation
Site 156
Moscow, Russian Federation
Site 155
Smolensk, Russian Federation
Site 159
St Petersburg, Russian Federation
Site 152
St. Petersburg, Russian Federation
Site 157
St. Petersburg, Russian Federation
Site 153
Yaroslav, Russian Federation
Site 160
Belgrade, Serbia
Site 161
Belgrade, Serbia
Site 162
Belgrade, Serbia
Site 163
Nis, Serbia
Site 170
Bratislava, Slovakia
Site 171
Bratislava, Slovakia
Site 174
Levice, Slovakia
Site 173
Nitra, Slovakia
Site 172
Zilina, Slovakia
South Africa
Site 250
Cape Town, South Africa
Site 252
Cape Town, South Africa
Site 251
Durban, South Africa
Site 253
Gauteng, South Africa
Site 254
Pretoria, South Africa
Site 127
Goteborg, Sweden
Site 126
Norrkoping, Sweden
Site 125
Stockholm, Sweden
Site 180
Kharkiv, Ukraine
Site 183
Kharkiv, Ukraine
Site 181
Kyiv, Ukraine
Site 182
Kyiv, Ukraine
Site 185
Lviv, Ukraine
Site 184
Vinnitsa, Ukraine
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Responsible Party: Erik van Leeuwen, Solvay Pharmaceuticals Identifier: NCT00332917     History of Changes
Other Study ID Numbers: S308.3.006
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: January 26, 2009
Last Verified: January 2009

Keywords provided by Solvay Pharmaceuticals:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases