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

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. Identifier: NCT00332917
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : January 26, 2009
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

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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

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

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.

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

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 identifier (NCT number): NCT00332917

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Sponsors and Collaborators
Solvay Pharmaceuticals
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

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Responsible Party: Erik van Leeuwen, Solvay Pharmaceuticals Identifier: NCT00332917    
Other Study ID Numbers: S308.3.006
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:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases