SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations
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.
2 other identifiers
interventional
295
12 countries
87
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2007
Shorter than P25 for phase_3
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFebruary 27, 2015
July 1, 2008
1.1 years
November 30, 2006
February 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
12 weeks
Secondary Outcomes (1)
Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39
12 weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- '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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (87)
Site 223
Birmingham, Alabama, United States
Site 220
La Jolla, California, United States
Site 211
San Francisco, California, United States
Site 214
Fort Lauderdale, Florida, United States
Site 218
Gainsville, Florida, United States
Site 213
Tampa, Florida, United States
Site 219
Augusta, Georgia, United States
Site 221
Chicago, Illinois, United States
Site 216
Kansas City, Kansas, United States
Site 224
Lexington, Kentucky, United States
Site 212
East Lansing, Michigan, United States
Site 217
St Louis, Missouri, United States
Site 222
Durham, North Carolina, United States
Site 210
Toledo, Ohio, United States
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
Córdoba, Argentina
Site 104
Mar del Plata, Argentina
Site 108
Santa Fe, Argentina
Site 114
Alto da Glória, Brazil
Site 113
Belo Horizonte, Brazil
Site 112
Campinas, Brazil
Site 116
Marília, Brazil
Site 111
Porto Alegre, Brazil
Site 118
Porto Alegre, Brazil
Site 117
Ribeirão Preto, Brazil
Site 119
Salvador, Brazil
Site 110
São Paulo, Brazil
Site 115
São Paulo, Brazil
Site 125
São 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, Chile
Site 141
Santiago, Chile
Site 143
Santiago, Chile
Site 142
Valdivia, Chile
Site 151
Bogotá, Colombia
Site 152
Bogotá, Colombia
Site 153
Bogotá, Colombia
Site 154
Bogotá, Colombia
Site 150
Medellín, 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
Site 193
Kazan', Russia
Site 190
Moscow, Russia
Site 194
Moscow, Russia
Site 197
Moscow, Russia
Site 191
Saint Petersburg, Russia
Site 192
Saint Petersburg, Russia
Site 195
Saint Petersburg, Russia
Site 198
Saint Petersburg, Russia
Site 196
Yaroslavl, Russia
Site 204
Dnipro, 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
Related Publications (1)
Rascol O, Bronzova J, Hauser RA, Lang AE, Sampaio C, Theeuwes A, van de Witte SV. Pardoprunox as adjunct therapy to levodopa in patients with Parkinson's disease experiencing motor fluctuations: results of a double-blind, randomized, placebo-controlled, trial. Parkinsonism Relat Disord. 2012 May;18(4):370-6. doi: 10.1016/j.parkreldis.2011.12.006. Epub 2012 Feb 7.
PMID: 22316635DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2006
First Posted
December 4, 2006
Study Start
March 1, 2007
Primary Completion
April 1, 2008
Study Completion
May 1, 2008
Last Updated
February 27, 2015
Record last verified: 2008-07