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| Sponsored by: |
Schering-Plough |
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00537017 |
Purpose
The purpose of this study is to assess the long term safety of SCH 420814 in subjects with moderate to severe Parkinson's Disease who are taking a L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All subjects must have participated in the main study (P04501) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias."
| Condition | Intervention | Phase |
|
Parkinson Disease Neurodegenerative Diseases Central Nervous System Diseases Movement Disorders Brain Diseases |
Drug: SCH 420814 |
Phase II |
| Genetics Home Reference related topics: | Parkinson disease |
| MedlinePlus related topics: | Brain Diseases Degenerative Nerve Diseases Movement Disorders Neurologic Diseases Parkinson's Disease |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 5 mg BID (Protocol No. P05175) |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| SCH 420814, 5 mg BID: Experimental |
Drug: SCH 420814
SCH 420814, 5 mg BID
|
Eligibility
| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
| United States, California | |||||
| Investigation Site 22 | Recruiting | ||||
| Fountain Valley, California, United States, 92708 | |||||
| Investigational Site 44 | Recruiting | ||||
| La Jolla, California, United States, 92037 | |||||
| United States, Georgia | |||||
| Investigational Site 21 | Recruiting | ||||
| Atlanta, Georgia, United States, 30329 | |||||
| Argentina | |||||
| Investigational Site 6 | Recruiting | ||||
| Ciudad Autonoma de Bue, Argentina, CP1135 | |||||
| Australia | |||||
| Investigational Site 20 | Recruiting | ||||
| Westmead, Australia, 2145 | |||||
| Canada | |||||
| Investigational Site 23 | Recruiting | ||||
| Quebec, Canada, G1R 3X5 | |||||
| Investigational Site 15 | Recruiting | ||||
| Montreal, Canada, H2L 4M1 | |||||
| Investigational Site 35 | Recruiting | ||||
| Halifax, Canada, B3J 3T1 | |||||
| Investigational Site 41 | Recruiting | ||||
| Ottawa, Canada, K1G 4G3 | |||||
| Chile | |||||
| Investigational Site 5 | Recruiting | ||||
| Santiago, Chile | |||||
| Colombia | |||||
| Investigational Site 14 | Recruiting | ||||
| Bucaramanga, Colombia | |||||
| Investigational Site 13 | Recruiting | ||||
| Bogota, Colombia, 01 | |||||
| France | |||||
| Investigational Site 17 | Recruiting | ||||
| Lille Cedex, France, 59037 | |||||
| Investigational Site 19 | Recruiting | ||||
| Marseille cedex 05, France, 13385 | |||||
| Guatemala | |||||
| Investigational Site 2 | Recruiting | ||||
| Guatemala, Guatemala | |||||
| Hong Kong | |||||
| Investigational Site 3 | Recruiting | ||||
| Hong Kong, Hong Kong | |||||
| Singapore | |||||
| Investigational Site 4 | Recruiting | ||||
| Singapore, Singapore, 169608 | |||||
| Spain | |||||
| Investigational Site 9 | Recruiting | ||||
| Barcelona, Spain | |||||
| Schering-Plough |
| Study Director: | Kenneth P Wolski | Schering-Plough |
More Information
| Responsible Party: | Schering-Plough ( Marc Cantillon, MD - Senior Director, Global Clinical Research, CNS ) |
| Study ID Numbers: | P05175, Preladenant;, Privadenant |
| First Received: | September 27, 2007 |
| Last Updated: | August 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00537017 |
| Health Authority: | United States: Food and Drug Administration |
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