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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00406588
First received: November 30, 2006
Last updated: July 1, 2008
Last verified: July 2008
History of Changes

November 30, 2006
July 1, 2008
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Advanced Stage Parkinson's Disease
  • Drug: Pardoprunox
    12-42mg
  • Drug: Placebo Comparator
    Placebo
  • Experimental: 1
    Intervention: Drug: 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. 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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Latvia,   Lithuania,   Peru,   Russian Federation,   Ukraine
 
NCT00406588
S308.3.002, 2006-005182-20
Yes
Joost Melis, 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