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An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

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ClinicalTrials.gov Identifier: NCT00332917
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : January 26, 2009
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.001 trial

Condition or disease Intervention/treatment Phase
Early Stage Parkinson's Disease Drug: Pardoprunox Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
Study Start Date : February 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Pardoprunox
12-42 mg



Primary Outcome Measures :
  1. Safety: laboratory data, adverse events, vital signs, ECG [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. UPDRS parts 1, 2 and 3, CGI-severity, CGI-improvement, PDQ-39 total score: all change from baseline [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have completed S308.3.001 trial

Exclusion Criteria:

  • Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.001

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): NCT00332917


  Show 130 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Responsible Party: Erik van Leeuwen, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00332917     History of Changes
Other Study ID Numbers: S308.3.006
2006-000858-45
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: January 26, 2009
Last Verified: January 2009

Keywords provided by Solvay Pharmaceuticals:
Parkinson's 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