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

September 10, 2010 updated by: Solvay Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Albania
      • Birmingham, Albania
        • S308.3.007 Site # 223
  • Argentina
      • Buenos Aires, Argentina
        • S308.3.007 Site # 100
      • Buenos Aires, Argentina
        • S308.3.007 Site # 101
      • Buenos Aires, Argentina
        • S308.3.007 Site # 102
      • Buenos Aires, Argentina
        • S308.3.007 Site # 103
      • Buenos Aires, Argentina
        • S308.3.007 Site # 106
      • Buenos Aires, Argentina
        • S308.3.007 Site # 107
      • Buenos Aires, Argentina
        • S308.3.007 Site # 109
      • Córdoba, Argentina
        • S308.3.007 Site # 105
      • Mar del Plata, Argentina
        • S308.3.007 Site # 104
      • Santa Fe, Argentina
        • S308.3.007 Site # 108
  • Brazil
      • Alto da Glória, Brazil
        • S308.3.007 Site # 114
      • Belo Horizonte, Brazil
        • S308.3.007 Site # 113
      • Campinas, Brazil
        • S308.3.007 Site # 112
      • Marília, Brazil
        • S308.3.007 Site # 116
      • Porto Alegre, Brazil
        • S308.3.007 Site # 111
      • Porto Alegre, Brazil
        • S308.3.007 Site # 118
      • Ribeirão Preto, Brazil
        • S308.3.007 Site # 117
      • Salvador, Brazil
        • S308.3.007 Site # 119
      • Sao Paulo, Brazil
        • S308.3.007 Site # 125
      • Sâo Paulo, Brazil
        • S308.3.007 Site # 115
      • São Paulo, Brazil
        • S308.3.007 Site # 110
  • Bulgaria
      • Plovdiv, Bulgaria
        • S308.3.007 Site # 123
      • Sofia, Bulgaria
        • S308.3.007 Site # 120
      • Sofia, Bulgaria
        • S308.3.007 Site # 121
      • Sofia, Bulgaria
        • S308.3.007 Site # 122
      • Sofia, Bulgaria
        • S308.3.007 Site # 124
  • Canada
      • Calgary, Canada
        • S308.3.007 Site # 136
      • Greenfield Park, Canada
        • S308.3.007 Site # 137
      • Halifax, Canada
        • S308.3.007 Site # 133
      • Markham, Canada
        • S308.3.007 Site # 132
      • Montreal, Canada
        • S308.3.007 Site # 130
      • Ottava, Canada
        • S308.3.007 Site # 134
      • Peterborough, Canada
        • S308.3.007 Site # 138
      • Sainte-Anne, Canada
        • S308.3.007 Site # 135
      • Toronto, Canada
        • S308.3.007 Site # 139
      • Windsor, Canada
        • S308.3.007 Site # 131
  • Chile
      • Santiago de Chile, Chile
        • S308.3.007 Site # 140
      • Santiago de Chile, Chile
        • S308.3.007 Site # 141
      • Santiago de Chile, Chile
        • S308.3.007 Site # 143
      • Valdivia, Chile
        • S308.3.007 Site # 142
  • Colombia
      • Bogota, Colombia
        • S308.3.007 Site # 151
      • Bogota, Colombia
        • S308.3.007 Site # 152
      • Bogota, Colombia
        • S308.3.007 Site # 153
      • Bogota, Colombia
        • S308.3.007 Site # 154
      • Medellin, Colombia
        • S308.3.007 Site # 150
  • Latvia
      • Riga, Latvia
        • S308.3.007 Site # 160
  • Lithuania
      • Kaunas, Lithuania
        • S308.3.007 Site # 172
      • Vilnius, Lithuania
        • S308.3.007 Site # 170
      • Vilnius, Lithuania
        • S308.3.007 Site # 171
  • Peru
      • Bellavista Callao, Peru
        • S308.3.007 Site # 184
      • Lima, Peru
        • S308.3.007 Site # 180
      • Lima, Peru
        • S308.3.007 Site # 181
      • Lima, Peru
        • S308.3.007 Site # 182
      • Lima, Peru
        • S308.3.007 Site # 183
  • Russian Federation
      • Kazan, Russian Federation
        • S308.3.007 Site # 193
      • Moscow, Russian Federation
        • S308.3.007 Site # 190
      • Moscow, Russian Federation
        • S308.3.007 Site # 194
      • Moscow, Russian Federation
        • S308.3.007 Site # 197
      • Saint-Petersburg, Russian Federation
        • S308.3.007 Site # 191
      • Saint-Petersburg, Russian Federation
        • S308.3.007 Site # 192
      • Saint-Petersburg, Russian Federation
        • S308.3.007 Site # 195
      • Saint-Petersburg, Russian Federation
        • S308.3.007 Site # 198
      • Yaroslavl, Russian Federation
        • S308.3.007 Site # 196
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • S308.3.007 Site # 204
      • Kharkiv, Ukraine
        • S308.3.007 Site # 206
      • Kyiv, Ukraine
        • S308.3.007 Site # 201
      • Kyiv, Ukraine
        • S308.3.007 Site # 202
      • Lviv, Ukraine
        • S308.3.007 Site # 205
      • Poltava, Ukraine
        • S308.3.007 Site # 203
      • Simferopol, Ukraine
        • S308.3.007 Site # 208
      • Vinnytsya, Ukraine
        • S308.3.007 Site # 200
      • Zaporozhya, Ukraine
        • S308.3.007 Site # 207
  • United States
    • California
      • LaJolla, California, United States
        • S308.3.007 Site # 220
      • San Francisco, California, United States
        • S308.3.007 Site # 211
    • Florida
      • Fort Lauderdale, Florida, United States
        • S308.3.007 Site # 214
      • Gainsville, Florida, United States
        • S308.3.007 Site # 218
      • Tampa, Florida, United States
        • S308.3.007 Site # 213
    • Georgia
      • Augusta, Georgia, United States
        • S308.3.007 Site # 219
    • Illinois
      • Chicago, Illinois, United States
        • S308.3.007 Site # 221
    • Kansas
      • Kansas City, Kansas, United States
        • S308.3.007 Site # 216
    • Kentucky
      • Lexington, Kentucky, United States
        • S308.3.007 Site # 224
    • Michigan
      • East Lansing, Michigan, United States
        • S308.3.007 Site # 212
    • Missouri
      • St. Louis, Missouri, United States
        • S308.3.007 Site # 217
    • North Carolina
      • Durham, North Carolina, United States
        • S308.3.007 Site # 222
    • Ohio
      • Tledo, Ohio, United States
        • S308.3.007 Site # 210
    • Texas
      • Houston, Texas, United States
        • S308.3.007 Site # 215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Pardoprunox
12-42 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: laboratory data, adverse events, vital signs, ECG
Time Frame: 36 weeks
36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Investigators

  • Study Director: Erik Vanleeuwen, Abbott Products

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

September 13, 2010

Last Update Submitted That Met QC Criteria

September 10, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S308.3.007
  • 2006-005183-91 (EudraCT Number)
  • 00407095 (Other Grant/Funding Number: NCT/NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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