SLV308 for Treatment of Patients With Early Parkinson's Disease

August 28, 2008 updated by: Solvay Pharmaceuticals

A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease

This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

468

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

  • Argentina
      • Buenos Aires, Argentina
        • Site 201
      • Buenos Aires, Argentina
        • Site 202
      • Buenos Aires, Argentina
        • Site 204
      • Buenos Aires, Argentina
        • Site 206
      • Capital Federal, CBA, Argentina
        • Site 208
      • Ciudad Autonoma de Buenos Aires, Argentina
        • Site 203
      • Ciudad de Buenos Aires, Argentina
        • Site 207
      • Cordoba, Argentina
        • Site 205
  • Belgium
      • Brussels, Belgium
        • Site 100
      • Genk, Belgium
        • Site 101
      • Wilrijk, Belgium
        • Site 102
  • Bulgaria
      • Plovdiv, Bulgaria
        • Site 107
      • Sofia, Bulgaria
        • Site 103
      • Sofia, Bulgaria
        • Site 104
      • Sofia, Bulgaria
        • Site 105
      • Sofia, Bulgaria
        • Site 106
  • Canada
      • Barrie, Canada
        • Site 268
      • Calgary, Canada
        • Site 260
      • Greenfield Park, Canada
        • Site 264
      • Markham, Canada
        • Site 263
      • Ottawa, Canada
        • Site 261
      • Ottawa, Canada
        • Site 266
      • Quebec, Canada
        • Site 262
      • Quebec, Canada
        • Site 265
      • Saskatoon, Canada
        • Site 269
      • Toronto, Canada
        • Site 267
  • Chile
      • Providencia, Chile
        • Site 213
      • San Miguel, Chile
        • Site 211
      • Santiago de Chile, Chile
        • Site 210
      • Valdivia, Chile
        • Site 212
  • Colombia
      • Bogota, Colombia
        • Site 221
      • Bogota, Colombia
        • Site 223
      • Bogota, Colombia
        • Site 224
      • Cali, Colombia
        • Site 222
      • Medellin, Colombia
        • Site 220
  • Croatia
      • Rijeka, Croatia
        • Site 111
      • Split, Croatia
        • Site 112
      • Zagreb, Croatia
        • Site 110
      • Zagreb, Croatia
        • Site 113
      • Zagreb, Croatia
        • Site 114
  • Finland
      • Kuopio, Finland
        • Site 123
      • Lappeenranta, Finland
        • Site 122
      • Oulun yliopisto, Finland
        • Site 120
      • Tampere, Finland
        • Site 121
      • Turku, Finland
        • Site 124
  • India
      • Bangalore, India
        • Site 196
      • Hyderabaad, India
        • Site 194
      • Mumbai, India
        • Site 193
      • Mumbai, India
        • Site 195
      • New Delhi, India
        • Site 199
      • Thiruvananthapuram, India
        • Site 198
      • Visakhapatnam, India
        • Site 197
  • Israel
      • Haifa, Israel
        • Site 131
      • Petach-Tikva, Israel
        • Site 132
      • Ramat-Gan, Israel
        • Site 133
      • Tel Aviv, Israel
        • Site 130
  • Mexico
      • Aguascalientes, Mexico
        • Site 232
      • Guadalajara - Jalisco, Mexico
        • Site 230
      • Monterrey N.L., Mexico
        • Site 231
      • Tlalpan, Mexico
        • Site 233
  • New Zealand
      • Christchurch, New Zealand
        • Site 191
      • Wellington South, New Zealand
        • Site 190
  • Peru
      • Barrios Altos-Lima, Peru
        • Site 244
      • La Victoria-Lima, Peru
        • Site 241
      • Lima, Peru
        • Site 240
      • San Isidro-Lima, Peru
        • Site 243
      • Surco-Lima, Peru
        • Site 242
  • Romania
      • Brasov, Romania
        • Site 143
      • Bucuresti, Romania
        • Site 140
      • Craiova, Romania
        • Site 141
      • Mures, Romania
        • Site 142
  • Russian Federation
      • Kazan, Russian Federation
        • Site 158
      • Moscow, Russian Federation
        • Site 150
      • Moscow, Russian Federation
        • Site 151
      • Moscow, Russian Federation
        • Site 154
      • Moscow, Russian Federation
        • Site 156
      • Smolensk, Russian Federation
        • Site 155
      • St Petersburg, Russian Federation
        • Site 159
      • St Petersburg, Russian Federation
        • Site 152
      • St Petersburg, Russian Federation
        • Site 157
      • Yaroslav, Russian Federation
        • Site 153
  • Serbia
      • Belgrade, Serbia
        • Site 160
      • Belgrade, Serbia
        • Site 161
      • Belgrade, Serbia
        • Site 162
      • Nis, Serbia
        • Site 163
  • Slovakia
      • Bratislava, Slovakia
        • Site 170
      • Bratislava, Slovakia
        • Site 171
      • Levice, Slovakia
        • Site 174
      • Nitra, Slovakia
        • Site 173
      • Zilina, Slovakia
        • Site 172
  • South Africa
      • Cape Town, South Africa
        • Site 250
      • Cape Town, South Africa
        • Site 252
      • Durban, South Africa
        • Site 251
      • Gauteng, South Africa
        • Site 253
      • Pretoria, South Africa
        • Site 254
  • Sweden
      • Goteborg, Sweden
        • Site 127
      • Norrkoping, Sweden
        • Site 126
      • Stockholm, Sweden
        • Site 125
  • Ukraine
      • Kharkiv, Ukraine
        • Site 180
      • Kharkiv, Ukraine
        • Site 183
      • Kyiv, Ukraine
        • Site 181
      • Kyiv, Ukraine
        • Site 182
      • Lviv, Ukraine
        • Site 185
      • Vinnytsya, Ukraine
        • Site 184
  • United States
    • Alabama
      • Huntsville, Alabama, United States
        • Site 284
    • Arkansas
      • Little Rock, Arkansas, United States
        • Site 274
    • California
      • Fountain Valley, California, United States
        • Site 283
      • La Jolla, California, United States
        • Site 277
      • San Francisco, California, United States
        • Site 271
    • Florida
      • Ft Lauderdale, Florida, United States
        • Site 279
      • Gainsville, Florida, United States
        • Site 293
      • Port Charlotte, Florida, United States
        • Site 282
      • Sunrise, Florida, United States
        • Site 285
      • Tampa, Florida, United States
        • Site 273
    • Illinois
      • Chicago, Illinois, United States
        • Site 290
    • Kansas
      • Kansas City, Kansas, United States
        • Site 280
    • Michigan
      • Bingham Farms, Michigan, United States
        • Site 292
      • Traverse City, Michigan, United States
        • Site 275
    • Missouri
      • St. Louis, Missouri, United States
        • Site 276
      • St. Louis, Missouri, United States
        • Site 287
    • Nevada
      • Las Vegas, Nevada, United States
        • Site 278
    • New York
      • Rochester, New York, United States
        • Site 286
    • North Carolina
      • Ashville, North Carolina, United States
        • Site 288
      • Charlotte, North Carolina, United States
        • Site 289
    • Ohio
      • Toledo, Ohio, United States
        • Site 294
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Site 281
    • Rhode Island
      • Warwick, Rhode Island, United States
        • Site 291
    • Texas
      • Houston, Texas, United States
        • Site 272

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:

  • Diagnosis of idiopathic Parkinson's Disease,
  • Early stage of disease, Modified Hoehn & Yahr up to stage III,
  • UPDRS motor score (part III) 10 at baseline.

Exclusion Criteria:

  • Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
  • Patients who have undergone surgery for the treatment of PD,
  • Presence of dyskinesias,
  • Motor fluctuations or loss of postural reflexes,
  • Clinically significant abnormalities,
  • Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
  • Antipsychotic.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: pardoprunox
fixed dose 6 mg
Experimental: 2
Drug: Pardoprunox
fixed dose 12 mg
Drug: Pardoprunox
12-42mg
Experimental: 3
Drug: Pardoprunox
fixed dose 12 mg
Drug: Pardoprunox
12-42mg
Placebo Comparator: 4
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Solvay Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 22, 2005

First Submitted That Met QC Criteria

December 22, 2005

First Posted (Estimate)

December 23, 2005

Study Record Updates

Last Update Posted (Estimate)

August 29, 2008

Last Update Submitted That Met QC Criteria

August 28, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S308.3.001

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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