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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:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00335374
First received: June 8, 2006
Last updated: February 5, 2009
Last verified: February 2009
History of Changes
  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
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 S308.3.003 in Early PD Patients

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: 24 weeks ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

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

Inclusion Criteria:

  • Patients who have completed S308.3.003 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335374

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

No publications provided

Responsible Party: Ellen van Kleef, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00335374     History of Changes
Other Study ID Numbers: S308.3.008, 2006-000859-18
Study First Received: June 8, 2006
Last Updated: February 5, 2009
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
India: Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Malaysia: Ministry of Health

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

ClinicalTrials.gov processed this record on October 16, 2012