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SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

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ClinicalTrials.gov Identifier: NCT00406588
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : February 27, 2015
Information provided by (Responsible Party):
Solvay Pharmaceuticals

Brief Summary:
This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance 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
Advanced Stage Parkinson's Disease Drug: Levodopa (Pardoprunox) Drug: Placebo Comparator Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
Study Start Date : March 2007
Primary Completion Date : April 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Levodopa (Pardoprunox)
Placebo Comparator: 2 Drug: Placebo Comparator

Primary Outcome Measures :
  1. Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39 [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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,
  • advance stage of disease,
  • Modified Hoehn & Yahr stage II-IV,
  • presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization

Exclusion Criteria:

  • 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,
  • Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,
  • Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,
  • Previous surgery for the treatment of PD

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 ClinicalTrials.gov identifier (NCT number): NCT00406588

  Show 87 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00406588     History of Changes
Other Study ID Numbers: S308.3.002
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: July 2008

Keywords provided by Solvay Pharmaceuticals:
Parkinson 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
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs