SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations
February 9, 2015 updated by: Solvay Pharmaceuticals
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
295
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina
- Site 100
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Buenos Aires, Argentina
- Site 101
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Buenos Aires, Argentina
- Site 102
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Buenos Aires, Argentina
- Site 103
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Buenos Aires, Argentina
- Site 106
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Buenos Aires, Argentina
- Site 107
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Buenos Aires, Argentina
- Site 109
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Cordoba, Argentina
- Site 105
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Mar del Plata, Argentina
- Site 104
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Santa Fe, Argentina
- Site 108
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Alto da Gloria, Brazil
- Site 114
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Belo Horizonte, Brazil
- Site 113
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Campinas, Brazil
- Site 112
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Marilia, Brazil
- Site 116
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Porto Alegre, Brazil
- Site 111
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Porto Alegre, Brazil
- Site 118
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Ribeirao Preto, Brazil
- Site 117
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Salvador, Brazil
- Site 119
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Sao Paulo, Brazil
- Site 110
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Sao Paulo, Brazil
- Site 115
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Sao Paulo, Brazil
- Site 125
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Plovdiv, Bulgaria
- Site 123
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Sofia, Bulgaria
- Site 120
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Sofia, Bulgaria
- Site 121
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Sofia, Bulgaria
- Site 122
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Sofia, Bulgaria
- Site 124
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Calgary, Canada
- Site 136
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Greenfield Park, Canada
- Site 137
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Halifax, Canada
- Site 133
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Markham, Canada
- Site 132
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Montreal, Canada
- Site 130
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Ottawa, Canada
- Site 134
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Peterborough, Canada
- Site 138
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Sainte-Anne, Canada
- Site 135
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Toronto, Canada
- Site 139
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Windsor, Canada
- Site 131
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Santiago de Chile, Chile
- Site 140
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Santiago de Chile, Chile
- Site 141
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Santiago de Chile, Chile
- Site 143
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Valdivia, Chile
- Site 142
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Bogota, Colombia
- Site 151
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Bogota, Colombia
- Site 152
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Bogota, Colombia
- Site 153
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Bogota, Colombia
- Site 154
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Medellin, Colombia
- Site 150
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Riga, Latvia
- Site 160
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Kaunas, Lithuania
- Site 172
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Vilnius, Lithuania
- Site 170
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Vilnius, Lithuania
- Site 171
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Bellavista Callao, Peru
- Site 184
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Lima, Peru
- Site 180
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Lima, Peru
- Site 181
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Lima, Peru
- Site 182
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Lima, Peru
- Site 183
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Kazan, Russian Federation
- Site 193
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Moscow, Russian Federation
- Site 190
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Moscow, Russian Federation
- Site 194
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Moscow, Russian Federation
- Site 197
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Saint Petersburg, Russian Federation
- Site 198
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Saint-Petersburg, Russian Federation
- Site 191
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Saint-Petersburg, Russian Federation
- Site 192
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Saint-Petersburg, Russian Federation
- Site 195
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Yaroslavl, Russian Federation
- Site 196
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Dnepropetrovsk, Ukraine
- Site 204
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Kharkiv, Ukraine
- Site 206
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Kyiv, Ukraine
- Site 201
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Kyiv, Ukraine
- Site 202
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Lviv, Ukraine
- Site 205
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Poltava, Ukraine
- Site 203
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Simferopol, Ukraine
- Site 208
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Vinnitsa, Ukraine
- Site 200
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Zaporizhya, Ukraine
- Site 207
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Alabama
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Birmingham, Alabama, United States
- Site 223
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California
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LaJolla, California, United States
- Site 220
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San Francisco, California, United States
- Site 211
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Florida
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Fort Lauderdale, Florida, United States
- Site 214
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Gainsville, Florida, United States
- Site 218
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Tampa, Florida, United States
- Site 213
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Georgia
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Augusta, Georgia, United States
- Site 219
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Illinois
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Chicago, Illinois, United States
- Site 221
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Kansas
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Kansas City, Kansas, United States
- Site 216
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Kentucky
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Lexington, Kentucky, United States
- Site 224
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Michigan
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East Lansing, Michigan, United States
- Site 212
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Missouri
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St. Louis, Missouri, United States
- Site 217
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North Carolina
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Durham, North Carolina, United States
- Site 222
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Ohio
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Toledo, Ohio, United States
- Site 210
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Texas
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Houston, Texas, United States
- Site 215
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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12-42mg
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Placebo Comparator: 2
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Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
November 30, 2006
First Submitted That Met QC Criteria
November 30, 2006
First Posted (Estimate)
December 4, 2006
Study Record Updates
Last Update Posted (Estimate)
February 27, 2015
Last Update Submitted That Met QC Criteria
February 9, 2015
Last Verified
July 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Levodopa
Other Study ID Numbers
- S308.3.002
- 2006-005182-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.