SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations
NCT ID: NCT00406588
Last Updated: 2015-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
295 participants
INTERVENTIONAL
2007-03-31
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
NCT00407095
SLV308 for Treatment of Patients With Early Parkinson's Disease
NCT00269516
Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease
NCT00134251
SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
NCT00335166
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
NCT00335374
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Levodopa (Pardoprunox)
12-42mg
2
Placebo Comparator
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Levodopa (Pardoprunox)
12-42mg
Placebo Comparator
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Solvay Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-005182-20
Identifier Type: -
Identifier Source: secondary_id
S308.3.002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.