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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00332917
First received: June 1, 2006
Last updated: January 23, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Early Stage Parkinson's Disease
Drug: Pardoprunox
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Safety: laboratory data, adverse events, vital signs, ECG [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • UPDRS parts 1, 2 and 3, CGI-severity, CGI-improvement, PDQ-39 total score: all change from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: February 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pardoprunox
12-42 mg

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332917

  Hide Study Locations
Locations
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
Chicago, Illinois, United States
United States, Kansas
Site 280
Kansas City, Kansas, United States
United States, Michigan
Site 292
Bingham Farms, Michigan, United States
Site 275
Traverse City, Michigan, United States
United States, Missouri
Site 276
St. Louis, Missouri, United States
Site 287
St. Louis, Missouri, United States
United States, Nevada
Site 278
Las Vegas, Nevada, United States
United States, New York
Site 286
Rochester, New York, United States
United States, North Carolina
Site 288
Ashville, North Carolina, United States
Site 289
Charlotte, North Carolina, United States
United States, Ohio
Site 294
Toledo, Ohio, United States
United States, Pennsylvania
Site 281
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Site 291
Warwick, Rhode Island, United States
United States, Texas
Site 272
Houston, Texas, United States
United States, Vermont
Site 270
Bennington, Vermont, United States
Argentina
Site 201
Buenos Aires, Argentina
Site 200
Buenos Aires, Argentina
Site 206
Buenos Aires, Argentina
Site 202
Buenos Aires, Argentina
Site 204
Buenos Aires, Argentina
Site 208
Capital Federal, CBA, Argentina
Site 203
Ciudad Autonoma de Buenos Aires, Argentina
Site 207
Ciudad de Buenos Aires, Argentina
Site 205
Cordoba, Argentina
Belgium
Site 100
Brussels, Belgium
Site 101
Genk, Belgium
Site 102
Wilrijk, Belgium
Bulgaria
Site 107
Plovdiv, Bulgaria
Site 103
Sofia, Bulgaria
Site 105
Sofia, Bulgaria
Site 104
Sofia, Bulgaria
Site 106
Sofia, Bulgaria
Canada
Site 268
Barrie, Canada
Site 260
Calgary, Canada
Site 264
Greenfield Park, Canada
Site 263
Markham, Canada
Site 261
Ottawa, Canada
Site 266
Ottawa, Canada
Site 265
Quebec, Canada
Site 262
Quebec, Canada
Site 269
Saskatoon, Canada
Site 267
Toronto, Canada
Chile
Site 213
Providencia, Chile
Site 211
San Miguel, Chile
Site 210
Santiago de Chile, Chile
Site 212
Valdivia, Chile
Colombia
Site 224
Bogota, Colombia
Site 223
Bogota, Colombia
Site 221
Bogota, Colombia
Site 222
Cali, Colombia
Site 220
Medellin, Colombia
Croatia
Site 111
Rijeka, Croatia
Site 112
Split, Croatia
Site 114
Zagreb, Croatia
Site 110
Zagreb, Croatia
Site 113
Zagreb, Croatia
Finland
Site 123
Kuopio, Finland
Site 122
Lappeenranta, Finland
Site 120
Oulun yliopisto, Finland
Site 121
Tampere, Finland
Site 124
Turku, Finland
India
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
Israel
Site 131
Haifa, Israel
Site 132
Petach-Tikva, Israel
Site 133
Ramat-Gan, Israel
Site 130
Tel Aviv, Israel
Mexico
Site 232
Aguascalientes, Mexico
Site 230
Guadalajara - Jalisco, Mexico
Site 231
Monterrey N.L., Mexico
Site 233
Tlalpan, Mexico
New Zealand
Site 191
Christchurch, New Zealand
Site 190
Wellington South, New Zealand
Peru
Site 244
Barrios Altos-Lima, Peru
Site 241
La Victoria-Lima, Peru
Site 240
Lima, Peru
Site 243
San Isidro-Lima, Peru
Site 242
Surco-Lima, Peru
Romania
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 157
St. Petersburg, Russian Federation
Site 152
St. Petersburg, Russian Federation
Site 153
Yaroslav, Russian Federation
Serbia
Site 161
Belgrade, Serbia
Site 160
Belgrade, Serbia
Site 162
Belgrade, Serbia
Site 163
Nis, Serbia
Slovakia
Site 170
Bratislava, Slovakia
Site 171
Bratislava, Slovakia
Site 174
Levice, Slovakia
Site 173
Nitra, Slovakia
Site 172
Zilina, Slovakia
South Africa
Site 252
Cape Town, South Africa
Site 250
Cape Town, South Africa
Site 251
Durban, South Africa
Site 253
Gauteng, South Africa
Site 254
Pretoria, South Africa
Sweden
Site 127
Goteborg, Sweden
Site 126
Norrkoping, Sweden
Site 125
Stockholm, Sweden
Ukraine
Site 183
Kharkiv, Ukraine
Site 180
Kharkiv, Ukraine
Site 181
Kyiv, Ukraine
Site 182
Kyiv, Ukraine
Site 185
Lviv, Ukraine
Site 184
Vinnitsa, Ukraine
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Erik van Leeuwen, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00332917     History of Changes
Other Study ID Numbers: S308.3.006, 2006-000858-45
Study First Received: June 1, 2006
Last Updated: January 23, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Finland: Finnish Medicines Agency
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency
Croatia: Ministry of Health and Social Care
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Gobierne de Chile
South Africa: Medicines Control Council
Canada: Health Canada
New Zealand: Medsafe
United States: Food and Drug Administration
Mexico: Federal Commission for Protection Against Health Risks
Colombia: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Peru: Ministry of Health

Keywords provided by Solvay Pharmaceuticals:
Parkinson's disease

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

ClinicalTrials.gov processed this record on October 23, 2014