SLV308 for Treatment of Patients With Early Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00269516
First received: December 22, 2005
Last updated: August 28, 2008
Last verified: August 2008

December 22, 2005
August 28, 2008
June 2006
December 2007   (final data collection date for primary outcome measure)
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00269516 on ClinicalTrials.gov Archive Site
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
SLV308 for Treatment of Patients With Early Parkinson's Disease
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

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.

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
Early Stage Parkinson's Disease
  • Drug: pardoprunox
    fixed dose 6 mg
  • Drug: Pardoprunox
    fixed dose 12 mg
  • Drug: Pardoprunox
    12-42mg
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: pardoprunox
  • Experimental: 2
    Intervention: Drug: Pardoprunox
  • Experimental: 3
    Intervention: Drug: Pardoprunox
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
468
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Finland,   India,   Israel,   Mexico,   New Zealand,   Peru,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Sweden,   Ukraine
 
NCT00269516
S308.3.001
Yes
Erik van Leeuwen, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
August 2008

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