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Sponsored by: |
Solvay Pharmaceuticals |
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Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00332917 |
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 |
Estimated Enrollment: | 300 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Pardoprunox
12-42 mg
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Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
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 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00332917 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines; Finland: National Agency for Medicines; 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 |
Parkinson's disease |
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Nervous System Diseases |