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

This study has been completed.

First Received: June 1, 2006 Last Updated: January 23, 2009 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00332917

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 S308.3.001 trial

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: SLV-308

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:	224
Study Start Date:	February 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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 S308.3.001 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332917

Show 130 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Erik van Leeuwen )
Study ID Numbers:	S308.3.006, 2006-000858-45
Study First Received:	June 1, 2006
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00332917 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Finland: Finnish Medicines Agency; Romania: National Medicines Agency; Slovakia: State Institute for Drug Control; Sweden: Medical Products Agency; Croatia: Ministry of Health and Social Care; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Chile: Gobierne de Chile; South Africa: Medicines Control Council; Canada: Health Canada; New Zealand: Medsafe; United States: Food and Drug Administration; Mexico: Federal Commission for Protection Against Health Risks; Colombia: Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Peru: Ministry of Health

Keywords provided by Solvay Pharmaceuticals:

Parkinson's disease

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 08, 2010