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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00406588
First Posted: December 4, 2006
Last Update Posted: February 27, 2015
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.
Information provided by (Responsible Party):
Solvay Pharmaceuticals
  Purpose
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 Intervention Phase
Advanced Stage Parkinson's Disease Drug: Levodopa (Pardoprunox) Drug: Placebo Comparator Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

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

Enrollment: 295
Study Start Date: March 2007
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Levodopa (Pardoprunox)
12-42mg
Placebo Comparator: 2 Drug: Placebo Comparator
Placebo

  Eligibility

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
Criteria

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
  Contacts and Locations
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
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

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
2006-005182-20
First Submitted: November 30, 2006
First Posted: December 4, 2006
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
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs