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

Primary Purpose

Advanced Stage Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levodopa (Pardoprunox)
Placebo Comparator
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Stage Parkinson's Disease focused on measuring Parkinson Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 223
  • Site 220
  • Site 211
  • Site 214
  • Site 218
  • Site 213
  • Site 219
  • Site 221
  • Site 216
  • Site 224
  • Site 212
  • Site 217
  • Site 222
  • Site 210
  • Site 215
  • Site 100
  • Site 101
  • Site 102
  • Site 103
  • Site 106
  • Site 107
  • Site 109
  • Site 105
  • Site 104
  • Site 108
  • Site 114
  • Site 113
  • Site 112
  • Site 116
  • Site 111
  • Site 118
  • Site 117
  • Site 119
  • Site 110
  • Site 115
  • Site 125
  • Site 123
  • Site 120
  • Site 121
  • Site 122
  • Site 124
  • Site 136
  • Site 137
  • Site 133
  • Site 132
  • Site 130
  • Site 134
  • Site 138
  • Site 135
  • Site 139
  • Site 131
  • Site 140
  • Site 141
  • Site 143
  • Site 142
  • Site 151
  • Site 152
  • Site 153
  • Site 154
  • Site 150
  • Site 160
  • Site 172
  • Site 170
  • Site 171
  • Site 184
  • Site 180
  • Site 181
  • Site 182
  • Site 183
  • Site 193
  • Site 190
  • Site 194
  • Site 197
  • Site 198
  • Site 191
  • Site 192
  • Site 195
  • Site 196
  • Site 204
  • Site 206
  • Site 201
  • Site 202
  • Site 205
  • Site 203
  • Site 208
  • Site 200
  • Site 207

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

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.

Secondary Outcome Measures

Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39

Full Information

First Posted
November 30, 2006
Last Updated
February 9, 2015
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00406588
Brief Title
SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations
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 Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Stage Parkinson's Disease
Keywords
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
295 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levodopa (Pardoprunox)
Intervention Description
12-42mg
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 223
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Site 220
City
LaJolla
State/Province
California
Country
United States
Facility Name
Site 211
City
San Francisco
State/Province
California
Country
United States
Facility Name
Site 214
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Site 218
City
Gainsville
State/Province
Florida
Country
United States
Facility Name
Site 213
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Site 219
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Site 221
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 216
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Site 224
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Site 212
City
East Lansing
State/Province
Michigan
Country
United States
Facility Name
Site 217
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 222
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Site 210
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Site 215
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 100
City
Buenos Aires
Country
Argentina
Facility Name
Site 101
City
Buenos Aires
Country
Argentina
Facility Name
Site 102
City
Buenos Aires
Country
Argentina
Facility Name
Site 103
City
Buenos Aires
Country
Argentina
Facility Name
Site 106
City
Buenos Aires
Country
Argentina
Facility Name
Site 107
City
Buenos Aires
Country
Argentina
Facility Name
Site 109
City
Buenos Aires
Country
Argentina
Facility Name
Site 105
City
Cordoba
Country
Argentina
Facility Name
Site 104
City
Mar del Plata
Country
Argentina
Facility Name
Site 108
City
Santa Fe
Country
Argentina
Facility Name
Site 114
City
Alto da Gloria
Country
Brazil
Facility Name
Site 113
City
Belo Horizonte
Country
Brazil
Facility Name
Site 112
City
Campinas
Country
Brazil
Facility Name
Site 116
City
Marilia
Country
Brazil
Facility Name
Site 111
City
Porto Alegre
Country
Brazil
Facility Name
Site 118
City
Porto Alegre
Country
Brazil
Facility Name
Site 117
City
Ribeirao Preto
Country
Brazil
Facility Name
Site 119
City
Salvador
Country
Brazil
Facility Name
Site 110
City
Sao Paulo
Country
Brazil
Facility Name
Site 115
City
Sao Paulo
Country
Brazil
Facility Name
Site 125
City
Sao Paulo
Country
Brazil
Facility Name
Site 123
City
Plovdiv
Country
Bulgaria
Facility Name
Site 120
City
Sofia
Country
Bulgaria
Facility Name
Site 121
City
Sofia
Country
Bulgaria
Facility Name
Site 122
City
Sofia
Country
Bulgaria
Facility Name
Site 124
City
Sofia
Country
Bulgaria
Facility Name
Site 136
City
Calgary
Country
Canada
Facility Name
Site 137
City
Greenfield Park
Country
Canada
Facility Name
Site 133
City
Halifax
Country
Canada
Facility Name
Site 132
City
Markham
Country
Canada
Facility Name
Site 130
City
Montreal
Country
Canada
Facility Name
Site 134
City
Ottawa
Country
Canada
Facility Name
Site 138
City
Peterborough
Country
Canada
Facility Name
Site 135
City
Sainte-Anne
Country
Canada
Facility Name
Site 139
City
Toronto
Country
Canada
Facility Name
Site 131
City
Windsor
Country
Canada
Facility Name
Site 140
City
Santiago de Chile
Country
Chile
Facility Name
Site 141
City
Santiago de Chile
Country
Chile
Facility Name
Site 143
City
Santiago de Chile
Country
Chile
Facility Name
Site 142
City
Valdivia
Country
Chile
Facility Name
Site 151
City
Bogota
Country
Colombia
Facility Name
Site 152
City
Bogota
Country
Colombia
Facility Name
Site 153
City
Bogota
Country
Colombia
Facility Name
Site 154
City
Bogota
Country
Colombia
Facility Name
Site 150
City
Medellin
Country
Colombia
Facility Name
Site 160
City
Riga
Country
Latvia
Facility Name
Site 172
City
Kaunas
Country
Lithuania
Facility Name
Site 170
City
Vilnius
Country
Lithuania
Facility Name
Site 171
City
Vilnius
Country
Lithuania
Facility Name
Site 184
City
Bellavista Callao
Country
Peru
Facility Name
Site 180
City
Lima
Country
Peru
Facility Name
Site 181
City
Lima
Country
Peru
Facility Name
Site 182
City
Lima
Country
Peru
Facility Name
Site 183
City
Lima
Country
Peru
Facility Name
Site 193
City
Kazan
Country
Russian Federation
Facility Name
Site 190
City
Moscow
Country
Russian Federation
Facility Name
Site 194
City
Moscow
Country
Russian Federation
Facility Name
Site 197
City
Moscow
Country
Russian Federation
Facility Name
Site 198
City
Saint Petersburg
Country
Russian Federation
Facility Name
Site 191
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Site 192
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Site 195
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Site 196
City
Yaroslavl
Country
Russian Federation
Facility Name
Site 204
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Site 206
City
Kharkiv
Country
Ukraine
Facility Name
Site 201
City
Kyiv
Country
Ukraine
Facility Name
Site 202
City
Kyiv
Country
Ukraine
Facility Name
Site 205
City
Lviv
Country
Ukraine
Facility Name
Site 203
City
Poltava
Country
Ukraine
Facility Name
Site 208
City
Simferopol
Country
Ukraine
Facility Name
Site 200
City
Vinnitsa
Country
Ukraine
Facility Name
Site 207
City
Zaporizhya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
22316635
Citation
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.
Results Reference
derived

Learn more about this trial

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

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