SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease

April 1, 2008 updated by: Solvay Pharmaceuticals

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

This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as 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 (Anticipated)

330

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

  • Australia
      • Bedford Park, Australia
        • 303
      • Cheltenham, Australia
        • 304
      • Concord, Australia
        • 301
      • Westmead, Australia
        • 302
  • Czech Republic
      • Kralove, Czech Republic
        • 315
      • Olomouc, Czech Republic
        • 313
      • Ostrava, Czech Republic
        • 310
      • Ostrava, Czech Republic
        • 314
      • Pardubice, Czech Republic
        • 312
      • Plzen, Czech Republic
        • 311
  • Estonia
      • Tallinn, Estonia
        • 320
      • Tartu, Estonia
        • 321
  • France
      • Aix en Provence, France
        • 323
      • Toulon, France
        • 324
      • Toulouse, France
        • 325
  • Germany
      • Bochum, Germany
        • 332
      • Gottingen, Germany
        • 331
      • Heidelberg, Germany
        • 329
      • Homburg, Germany
        • 327
      • Leipzig, Germany
        • 330
      • Lubeck, Germany
        • 328
      • Wiesbaden, Germany
        • 326
  • India
      • Bangalore, India
        • 338
      • Hyderabad, India
        • 339
      • Kerala, India
        • 337
      • Mumbai, India
        • 336
      • Mumbai, India
        • 340
  • Italy
      • Arcugnano (VI), Italy
        • 347
      • Grosseto GR, Italy
        • 348
      • Lido di Camaiore (LU), Italy
        • 346
      • Pescara, Italy
        • 344
      • Roma, Italy
        • 343
      • Roma, Italy
        • 345
  • Lithuania
      • Kaunas, Lithuania
        • 428
      • Vilnius, Lithuania
        • 427
      • Vilnius, Lithuania
        • 429
  • Malaysia
      • Kelantan, Malaysia
        • 355
      • Kuala Lumpur, Malaysia
        • 357
      • Pulau Pinang, Malaysia
        • 356
  • Netherlands
      • Eindhoven, Netherlands
        • 364
      • Emmen, Netherlands
        • 363
      • Groningen, Netherlands
        • 362
      • Hertogenbosch, Netherlands
        • 361
      • RM Groningen, Netherlands
        • 360
  • Poland
      • Gdansk, Poland
        • 373
      • Kalisz, Poland
        • 371
      • Katowice, Poland
        • 369
      • Katowice, Poland
        • 374
      • Krakow, Poland
        • 365
      • Leszno, Poland
        • 368
      • Lublin, Poland
        • 366
      • Mosina, Poland
        • 370
      • Torun, Poland
        • 367
  • Portugal
      • Coimbra, Portugal
        • 376
      • Lisboa, Portugal
        • 375
  • South Africa
      • Cape Town, South Africa
        • 377
      • Cape Town, South Africa
        • 378
      • Gauteng, South Africa
        • 380
      • Pretoria, South Africa
        • 381
      • Sandton, South Africa
        • 379
  • Spain
      • Barcelona, Spain
        • 383
      • Colmenar Viejo, Spain
        • 384
      • San Sebastian, Spain
        • 382
  • Taiwan
      • Hualien, Taiwan
        • 388
      • Kaohsiung, Taiwan
        • 387
      • Kaohsiung Hsien, Taiwan
        • 389
      • Kweishan, Taiwan
        • 386
      • Taipei, Taiwan
        • 385
  • Thailand
      • Bangkok, Thailand
        • 391
      • Bangkok, Thailand
        • 393
      • Ubonratchathani Province, Thailand
        • 394
  • United Kingdom
      • Blackpool, United Kingdom
        • 396
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 419
    • California
      • Oceanside, California, United States
        • 413
      • Oxnard, California, United States
        • 408
    • Connecticut
      • New Haven, Connecticut, United States
        • 422
    • Florida
      • Boca Raton, Florida, United States
        • 403
      • Sarasota, Florida, United States
        • 411
    • Georgia
      • Augusta, Georgia, United States
        • 421
    • Indiana
      • Ft Wayne, Indiana, United States
        • 410
    • Kentucky
      • Lexington, Kentucky, United States
        • 417
    • Massachusetts
      • Boston, Massachusetts, United States
        • 405
      • Boston, Massachusetts, United States
        • 420
    • Michigan
      • Grand Rapids, Michigan, United States
        • 415
    • Minnesota
      • Golden Valley, Minnesota, United States
        • 416
      • Minneapolis, Minnesota, United States
        • 406
    • New York
      • Albany, New York, United States
        • 418
    • North Carolina
      • Charlotte, North Carolina, United States
        • 424
      • Raleigh, North Carolina, United States
        • 412

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, Modified Hoehn & Yahr up to stage III, UPDRS motor score (part III) must have a total of at least 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,
  • Current presence of dyskinesias,
  • Motor fluctuations or loss of postural reflexes,
  • A history of non-response to an adequate course of l-dopa or a dopamine agonist,
  • Patients for whom previously treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and /or sleep attacks.

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: Pardaprunox
12-42 mg
Active Comparator: 2
Drug: pramipexole
1.5-4.5 mg
Placebo Comparator: 3
Drug: Placebo Comparator
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: 24 weeks
24 weeks

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: 24 weeks
24 weeks

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

November 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

June 8, 2006

First Submitted That Met QC Criteria

June 8, 2006

First Posted (Estimate)

June 9, 2006

Study Record Updates

Last Update Posted (Estimate)

April 3, 2008

Last Update Submitted That Met QC Criteria

April 1, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S308.3.003
  • Not requested yet

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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