SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

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: NCT00406588
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : February 27, 2015
Information provided by (Responsible Party):
Solvay Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Stage Parkinson's Disease Drug: Levodopa (Pardoprunox) Drug: Placebo Comparator Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : March 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Levodopa (Pardoprunox)
Placebo Comparator: 2 Drug: Placebo Comparator

Primary Outcome Measures :
  1. Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39 [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00406588

  Hide Study Locations
United States, Alabama
Site 223
Birmingham, Alabama, United States
United States, California
Site 220
LaJolla, California, United States
Site 211
San Francisco, California, United States
United States, Florida
Site 214
Fort Lauderdale, Florida, United States
Site 218
Gainsville, Florida, United States
Site 213
Tampa, Florida, United States
United States, Georgia
Site 219
Augusta, Georgia, United States
United States, Illinois
Site 221
Chicago, Illinois, United States
United States, Kansas
Site 216
Kansas City, Kansas, United States
United States, Kentucky
Site 224
Lexington, Kentucky, United States
United States, Michigan
Site 212
East Lansing, Michigan, United States
United States, Missouri
Site 217
St. Louis, Missouri, United States
United States, North Carolina
Site 222
Durham, North Carolina, United States
United States, Ohio
Site 210
Toledo, Ohio, United States
United States, Texas
Site 215
Houston, Texas, United States
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, Argentina
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, Brazil
Site 123
Plovdiv, Bulgaria
Site 120
Sofia, Bulgaria
Site 121
Sofia, Bulgaria
Site 122
Sofia, Bulgaria
Site 124
Sofia, Bulgaria
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, Canada
Site 140
Santiago de Chile, Chile
Site 141
Santiago de Chile, Chile
Site 143
Santiago de Chile, Chile
Site 142
Valdivia, Chile
Site 151
Bogota, Colombia
Site 152
Bogota, Colombia
Site 153
Bogota, Colombia
Site 154
Bogota, Colombia
Site 150
Medellin, Colombia
Site 160
Riga, Latvia
Site 172
Kaunas, Lithuania
Site 170
Vilnius, Lithuania
Site 171
Vilnius, Lithuania
Site 184
Bellavista Callao, Peru
Site 180
Lima, Peru
Site 181
Lima, Peru
Site 182
Lima, Peru
Site 183
Lima, Peru
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, Russian Federation
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, Ukraine
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Solvay Pharmaceuticals Identifier: NCT00406588     History of Changes
Other Study ID Numbers: S308.3.002
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: July 2008

Keywords provided by Solvay Pharmaceuticals:
Parkinson 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
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs