An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients - Full Text View

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00335374

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 III

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

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 S308.3.003 in Early PD Patients

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
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 S308.3.003 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

Responsible Party:	Solvay Pharmaceuticals ( Ellen van Kleef )
Study ID Numbers:	S308.3.008, 2006-000859-18
Study First Received:	June 8, 2006
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00335374
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 - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009