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An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00335374
First Posted: June 9, 2006
Last Update Posted: February 6, 2009
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:
Solvay Pharmaceuticals
  Purpose
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 S308.3.003 trial

Condition Intervention Phase
Early Stage Parkinson's Disease Drug: Pardoprunox Phase 3

Study Type: Interventional
Study Design: 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 S308.3.003 in Early PD Patients

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

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

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

Enrollment: 202
Study Start Date: August 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pardoprunox
12 -42 mg

  Eligibility

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.


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 S308.3.003 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 S308.3.003
  Contacts and Locations
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): NCT00335374


  Show 75 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: Ellen van Kleef, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00335374     History of Changes
Other Study ID Numbers: S308.3.008
2006-000859-18
First Submitted: June 8, 2006
First Posted: June 9, 2006
Last Update Posted: February 6, 2009
Last Verified: February 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