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An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00407095
First received: November 30, 2006
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Safety: laboratory data, adverse events, vital signs, ECG [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pardoprunox
12-42 mg/day

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Patients who have completed S308.3.002 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 S308.3.002

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407095

  Show 87 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Erik Vanleeuwen Abbott Products
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00407095     History of Changes
Other Study ID Numbers: S308.3.007, 2006-005183-91, 00407095
Study First Received: November 30, 2006
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Parkinson 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

ClinicalTrials.gov processed this record on May 23, 2013