SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations - Full Text View

Purpose

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	Intervention	Phase
Advanced Stage Parkinson's Disease	Drug: Pardoprunox Drug: Placebo Comparator	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	295
Study Start Date:	March 2007
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Pardoprunox 12-42mg
Placebo Comparator: 2	Drug: Placebo Comparator Placebo

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406588

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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
Argentina
Site 101
Buenos Aires, Argentina
Site 106
Buenos Aires, Argentina
Site 103
Buenos Aires, Argentina
Site 102
Buenos Aires, Argentina
Site 109
Buenos Aires, Argentina
Site 100
Buenos Aires, Argentina
Site 107
Buenos Aires, Argentina
Site 105
Cordoba, Argentina
Site 104
Mar del Plata, Argentina
Site 108
Santa Fe, Argentina
Brazil
Site 114
Alto da Gloria, Brazil
Site 113
Belo Horizonte, Brazil
Site 112
Campinas, Brazil
Site 116
Marilia, Brazil
Site 118
Porto Alegre, Brazil
Site 111
Porto Alegre, Brazil
Site 117
Ribeirao Preto, Brazil
Site 119
Salvador, Brazil
Site 110
Sao Paulo, Brazil
Site 125
Sao Paulo, Brazil
Site 115
Sao Paulo, Brazil
Bulgaria
Site 123
Plovdiv, Bulgaria
Site 121
Sofia, Bulgaria
Site 120
Sofia, Bulgaria
Site 122
Sofia, Bulgaria
Site 124
Sofia, Bulgaria
Canada
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
Chile
Site 143
Santiago de Chile, Chile
Site 140
Santiago de Chile, Chile
Site 141
Santiago de Chile, Chile
Site 142
Valdivia, Chile
Colombia
Site 151
Bogota, Colombia
Site 152
Bogota, Colombia
Site 153
Bogota, Colombia
Site 154
Bogota, Colombia
Site 150
Medellin, Colombia
Latvia
Site 160
Riga, Latvia
Lithuania
Site 172
Kaunas, Lithuania
Site 170
Vilnius, Lithuania
Site 171
Vilnius, Lithuania
Peru
Site 184
Bellavista Callao, Peru
Site 180
Lima, Peru
Site 181
Lima, Peru
Site 183
Lima, Peru
Site 182
Lima, Peru
Russian Federation
Site 193
Kazan, Russian Federation
Site 190
Moscow, Russian Federation
Site 197
Moscow, Russian Federation
Site 194
Moscow, Russian Federation
Site 198
Saint Petersburg, Russian Federation
Site 195
Saint-Petersburg, Russian Federation
Site 191
Saint-Petersburg, Russian Federation
Site 192
Saint-Petersburg, Russian Federation
Site 196
Yaroslavl, Russian Federation
Ukraine
Site 204
Dnepropetrovsk, Ukraine
Site 206
Kharkiv, Ukraine
Site 202
Kyiv, Ukraine
Site 201
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

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided by Solvay Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2012 Feb 7.

Responsible Party:	Joost Melis, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00406588 History of Changes
Other Study ID Numbers:	S308.3.002, 2006-005182-20
Study First Received:	November 30, 2006
Last Updated:	July 1, 2008
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013