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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
November 30, 2006
December 4, 2006
February 27, 2015
March 2007
April 2008   (Final data collection date for primary outcome measure)
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 ]
Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries.
Complete list of historical versions of study NCT00406588 on ClinicalTrials.gov Archive Site
Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39 [ Time Frame: 12 weeks ]
Increase of 'on'-time, change from baseline in the total score of the UPDRS, PDQ-39
Not Provided
Not Provided
 
SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Advanced Stage Parkinson's Disease
  • Drug: Levodopa (Pardoprunox)
    12-42mg
  • Drug: Placebo Comparator
    Placebo
  • Experimental: 1
    Intervention: Drug: Levodopa (Pardoprunox)
  • Placebo Comparator: 2
    Intervention: Drug: Placebo Comparator
Rascol O, Bronzova J, Hauser RA, Lang AE, Sampaio C, Theeuwes A, van de Witte SV. Pardoprunox as adjunct therapy to levodopa in patients with Parkinson's disease experiencing motor fluctuations: results of a double-blind, randomized, placebo-controlled, trial. Parkinsonism Relat Disord. 2012 May;18(4):370-6. doi: 10.1016/j.parkreldis.2011.12.006. Epub 2012 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
295
May 2008
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Latvia,   Lithuania,   Peru,   Russian Federation,   Ukraine,   United States
 
 
NCT00406588
S308.3.002
2006-005182-20
Yes
Not Provided
Not Provided
Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP