SLV308 for Treatment of Patients With Early Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00269516
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : August 29, 2008
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Early Stage Parkinson's Disease Drug: pardoprunox Drug: Pardoprunox Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: pardoprunox
fixed dose 6 mg
Experimental: 2 Drug: Pardoprunox
fixed dose 12 mg
Experimental: 3 Drug: Pardoprunox
Placebo Comparator: 4 Drug: Placebo

Primary Outcome Measures :
  1. UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00269516

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United States, Alabama
Site 284
Huntsville, Alabama, United States
United States, Arkansas
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Little Rock, Arkansas, United States
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Fountain Valley, California, United States
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Yaroslav, Russian Federation
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Belgrade, Serbia
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Nis, Serbia
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Bratislava, Slovakia
Site 174
Levice, Slovakia
Site 173
Nitra, Slovakia
Site 172
Zilina, Slovakia
South Africa
Site 250
Cape Town, South Africa
Site 252
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Site 251
Durban, South Africa
Site 253
Gauteng, South Africa
Site 254
Pretoria, South Africa
Site 127
Goteborg, Sweden
Site 126
Norrkoping, Sweden
Site 125
Stockholm, Sweden
Site 180
Kharkiv, Ukraine
Site 183
Kharkiv, Ukraine
Site 181
Kyiv, Ukraine
Site 182
Kyiv, Ukraine
Site 185
Lviv, Ukraine
Site 184
Vinnytsya, Ukraine
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Erik van Leeuwen, Solvay Pharmaceuticals Identifier: NCT00269516     History of Changes
Other Study ID Numbers: S308.3.001
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: August 29, 2008
Last Verified: August 2008

Keywords provided by Solvay Pharmaceuticals:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases