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An Open Label SLV308 Safety Extension to Study S308.3.002 in 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
Pardoprunox
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 Patients who have completed S308.3.002 trial Exclusion Criteria Patients with medically relevant abnormal findings (ECG, physical examination, Aes) at end of the maintenance phase (visit M6, week 24) of study S308.3.002

Sites / Locations

  • S308.3.007 Site # 220
  • S308.3.007 Site # 211
  • S308.3.007 Site # 214
  • S308.3.007 Site # 218
  • S308.3.007 Site # 213
  • S308.3.007 Site # 219
  • S308.3.007 Site # 221
  • S308.3.007 Site # 216
  • S308.3.007 Site # 224
  • S308.3.007 Site # 212
  • S308.3.007 Site # 217
  • S308.3.007 Site # 222
  • S308.3.007 Site # 210
  • S308.3.007 Site # 215
  • S308.3.007 Site # 223
  • S308.3.007 Site # 100
  • S308.3.007 Site # 101
  • S308.3.007 Site # 102
  • S308.3.007 Site # 103
  • S308.3.007 Site # 106
  • S308.3.007 Site # 107
  • S308.3.007 Site # 109
  • S308.3.007 Site # 105
  • S308.3.007 Site # 104
  • S308.3.007 Site # 108
  • S308.3.007 Site # 114
  • S308.3.007 Site # 113
  • S308.3.007 Site # 112
  • S308.3.007 Site # 116
  • S308.3.007 Site # 111
  • S308.3.007 Site # 118
  • S308.3.007 Site # 117
  • S308.3.007 Site # 119
  • S308.3.007 Site # 125
  • S308.3.007 Site # 115
  • S308.3.007 Site # 110
  • S308.3.007 Site # 123
  • S308.3.007 Site # 120
  • S308.3.007 Site # 121
  • S308.3.007 Site # 122
  • S308.3.007 Site # 124
  • S308.3.007 Site # 136
  • S308.3.007 Site # 137
  • S308.3.007 Site # 133
  • S308.3.007 Site # 132
  • S308.3.007 Site # 130
  • S308.3.007 Site # 134
  • S308.3.007 Site # 138
  • S308.3.007 Site # 135
  • S308.3.007 Site # 139
  • S308.3.007 Site # 131
  • S308.3.007 Site # 140
  • S308.3.007 Site # 141
  • S308.3.007 Site # 143
  • S308.3.007 Site # 142
  • S308.3.007 Site # 151
  • S308.3.007 Site # 152
  • S308.3.007 Site # 153
  • S308.3.007 Site # 154
  • S308.3.007 Site # 150
  • S308.3.007 Site # 160
  • S308.3.007 Site # 172
  • S308.3.007 Site # 170
  • S308.3.007 Site # 171
  • S308.3.007 Site # 184
  • S308.3.007 Site # 180
  • S308.3.007 Site # 181
  • S308.3.007 Site # 182
  • S308.3.007 Site # 183
  • S308.3.007 Site # 193
  • S308.3.007 Site # 190
  • S308.3.007 Site # 194
  • S308.3.007 Site # 197
  • S308.3.007 Site # 191
  • S308.3.007 Site # 192
  • S308.3.007 Site # 195
  • S308.3.007 Site # 198
  • S308.3.007 Site # 196
  • S308.3.007 Site # 204
  • S308.3.007 Site # 206
  • S308.3.007 Site # 201
  • S308.3.007 Site # 202
  • S308.3.007 Site # 205
  • S308.3.007 Site # 203
  • S308.3.007 Site # 208
  • S308.3.007 Site # 200
  • S308.3.007 Site # 207

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Safety: laboratory data, adverse events, vital signs, ECG

Secondary Outcome Measures

On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline

Full Information

First Posted
November 30, 2006
Last Updated
September 10, 2010
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00407095
Brief Title
An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
Official Title
An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pardoprunox
Intervention Description
12-42 mg/day
Primary Outcome Measure Information:
Title
Safety: laboratory data, adverse events, vital signs, ECG
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients who have completed S308.3.002 trial Exclusion Criteria Patients with medically relevant abnormal findings (ECG, physical examination, Aes) at end of the maintenance phase (visit M6, week 24) of study S308.3.002
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Vanleeuwen
Organizational Affiliation
Abbott Products
Official's Role
Study Director
Facility Information:
Facility Name
S308.3.007 Site # 220
City
LaJolla
State/Province
California
Country
United States
Facility Name
S308.3.007 Site # 211
City
San Francisco
State/Province
California
Country
United States
Facility Name
S308.3.007 Site # 214
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
S308.3.007 Site # 218
City
Gainsville
State/Province
Florida
Country
United States
Facility Name
S308.3.007 Site # 213
City
Tampa
State/Province
Florida
Country
United States
Facility Name
S308.3.007 Site # 219
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
S308.3.007 Site # 221
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
S308.3.007 Site # 216
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
S308.3.007 Site # 224
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
S308.3.007 Site # 212
City
East Lansing
State/Province
Michigan
Country
United States
Facility Name
S308.3.007 Site # 217
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
S308.3.007 Site # 222
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
S308.3.007 Site # 210
City
Tledo
State/Province
Ohio
Country
United States
Facility Name
S308.3.007 Site # 215
City
Houston
State/Province
Texas
Country
United States
Facility Name
S308.3.007 Site # 223
City
Birmingham
Country
Albania
Facility Name
S308.3.007 Site # 100
City
Buenos Aires
Country
Argentina
Facility Name
S308.3.007 Site # 101
City
Buenos Aires
Country
Argentina
Facility Name
S308.3.007 Site # 102
City
Buenos Aires
Country
Argentina
Facility Name
S308.3.007 Site # 103
City
Buenos Aires
Country
Argentina
Facility Name
S308.3.007 Site # 106
City
Buenos Aires
Country
Argentina
Facility Name
S308.3.007 Site # 107
City
Buenos Aires
Country
Argentina
Facility Name
S308.3.007 Site # 109
City
Buenos Aires
Country
Argentina
Facility Name
S308.3.007 Site # 105
City
Córdoba
Country
Argentina
Facility Name
S308.3.007 Site # 104
City
Mar del Plata
Country
Argentina
Facility Name
S308.3.007 Site # 108
City
Santa Fe
Country
Argentina
Facility Name
S308.3.007 Site # 114
City
Alto da Glória
Country
Brazil
Facility Name
S308.3.007 Site # 113
City
Belo Horizonte
Country
Brazil
Facility Name
S308.3.007 Site # 112
City
Campinas
Country
Brazil
Facility Name
S308.3.007 Site # 116
City
Marília
Country
Brazil
Facility Name
S308.3.007 Site # 111
City
Porto Alegre
Country
Brazil
Facility Name
S308.3.007 Site # 118
City
Porto Alegre
Country
Brazil
Facility Name
S308.3.007 Site # 117
City
Ribeirão Preto
Country
Brazil
Facility Name
S308.3.007 Site # 119
City
Salvador
Country
Brazil
Facility Name
S308.3.007 Site # 125
City
Sao Paulo
Country
Brazil
Facility Name
S308.3.007 Site # 115
City
Sâo Paulo
Country
Brazil
Facility Name
S308.3.007 Site # 110
City
São Paulo
Country
Brazil
Facility Name
S308.3.007 Site # 123
City
Plovdiv
Country
Bulgaria
Facility Name
S308.3.007 Site # 120
City
Sofia
Country
Bulgaria
Facility Name
S308.3.007 Site # 121
City
Sofia
Country
Bulgaria
Facility Name
S308.3.007 Site # 122
City
Sofia
Country
Bulgaria
Facility Name
S308.3.007 Site # 124
City
Sofia
Country
Bulgaria
Facility Name
S308.3.007 Site # 136
City
Calgary
Country
Canada
Facility Name
S308.3.007 Site # 137
City
Greenfield Park
Country
Canada
Facility Name
S308.3.007 Site # 133
City
Halifax
Country
Canada
Facility Name
S308.3.007 Site # 132
City
Markham
Country
Canada
Facility Name
S308.3.007 Site # 130
City
Montreal
Country
Canada
Facility Name
S308.3.007 Site # 134
City
Ottava
Country
Canada
Facility Name
S308.3.007 Site # 138
City
Peterborough
Country
Canada
Facility Name
S308.3.007 Site # 135
City
Sainte-Anne
Country
Canada
Facility Name
S308.3.007 Site # 139
City
Toronto
Country
Canada
Facility Name
S308.3.007 Site # 131
City
Windsor
Country
Canada
Facility Name
S308.3.007 Site # 140
City
Santiago de Chile
Country
Chile
Facility Name
S308.3.007 Site # 141
City
Santiago de Chile
Country
Chile
Facility Name
S308.3.007 Site # 143
City
Santiago de Chile
Country
Chile
Facility Name
S308.3.007 Site # 142
City
Valdivia
Country
Chile
Facility Name
S308.3.007 Site # 151
City
Bogota
Country
Colombia
Facility Name
S308.3.007 Site # 152
City
Bogota
Country
Colombia
Facility Name
S308.3.007 Site # 153
City
Bogota
Country
Colombia
Facility Name
S308.3.007 Site # 154
City
Bogota
Country
Colombia
Facility Name
S308.3.007 Site # 150
City
Medellin
Country
Colombia
Facility Name
S308.3.007 Site # 160
City
Riga
Country
Latvia
Facility Name
S308.3.007 Site # 172
City
Kaunas
Country
Lithuania
Facility Name
S308.3.007 Site # 170
City
Vilnius
Country
Lithuania
Facility Name
S308.3.007 Site # 171
City
Vilnius
Country
Lithuania
Facility Name
S308.3.007 Site # 184
City
Bellavista Callao
Country
Peru
Facility Name
S308.3.007 Site # 180
City
Lima
Country
Peru
Facility Name
S308.3.007 Site # 181
City
Lima
Country
Peru
Facility Name
S308.3.007 Site # 182
City
Lima
Country
Peru
Facility Name
S308.3.007 Site # 183
City
Lima
Country
Peru
Facility Name
S308.3.007 Site # 193
City
Kazan
Country
Russian Federation
Facility Name
S308.3.007 Site # 190
City
Moscow
Country
Russian Federation
Facility Name
S308.3.007 Site # 194
City
Moscow
Country
Russian Federation
Facility Name
S308.3.007 Site # 197
City
Moscow
Country
Russian Federation
Facility Name
S308.3.007 Site # 191
City
Saint-Petersburg
Country
Russian Federation
Facility Name
S308.3.007 Site # 192
City
Saint-Petersburg
Country
Russian Federation
Facility Name
S308.3.007 Site # 195
City
Saint-Petersburg
Country
Russian Federation
Facility Name
S308.3.007 Site # 198
City
Saint-Petersburg
Country
Russian Federation
Facility Name
S308.3.007 Site # 196
City
Yaroslavl
Country
Russian Federation
Facility Name
S308.3.007 Site # 204
City
Dnepropetrovsk
Country
Ukraine
Facility Name
S308.3.007 Site # 206
City
Kharkiv
Country
Ukraine
Facility Name
S308.3.007 Site # 201
City
Kyiv
Country
Ukraine
Facility Name
S308.3.007 Site # 202
City
Kyiv
Country
Ukraine
Facility Name
S308.3.007 Site # 205
City
Lviv
Country
Ukraine
Facility Name
S308.3.007 Site # 203
City
Poltava
Country
Ukraine
Facility Name
S308.3.007 Site # 208
City
Simferopol
Country
Ukraine
Facility Name
S308.3.007 Site # 200
City
Vinnytsya
Country
Ukraine
Facility Name
S308.3.007 Site # 207
City
Zaporozhya
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

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