Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175AM1) - Tabular View

Tracking Information
First Received Date ^ICMJE	September 27, 2007
Last Updated Date	November 5, 2009
Start Date ^ICMJE	November 2007
Estimated Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	Proportion of subjects reporting AEs [ Time Frame: 36 weeks of open-label treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00537017 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 20, 2007)	Laboratory results, and vital signs assessments. Efficacy data: Hours awake/d in "on" state; hours/d in"off" state, "on" state with no dyskinesias, "on" state with troublesome dyskinesias, "on" state w/o troublesome dyskinesias; total sleep time [ Time Frame: 36 weeks of open-label treatment ] [ Designated as safety issue: Yes ] Laboratory results, and vital signs assessments. Efficacy data: Absolute duration of dyskinesias [ Time Frame: 36 weeks of open-label treatment ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175AM1)
Official Title ^ICMJE	A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 5 mg BID (Protocol No. P05175)
Brief Summary	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."
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition ^ICMJE	Parkinson Disease Neurodegenerative Diseases Central Nervous System Diseases Movement Disorders Brain Diseases
Intervention ^ICMJE	Drug: SCH 420814
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	November 2009
Estimated Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects must have participated in P04501. Subjects must be >=30 years of age, with a diagnosis of moderate to severe idiopathic Parkinson's disease. Subjects must have been on a regimen of L-Dopa and/or a dopamine agonist. Exclusion Criteria: Subjects who discontinued from Study P04501 because they experienced a serious adverse event (SAE) Subjects with any form of drug-induced or atypical parkinsonism, cognitive impairment, or psychosis Subjects taking tolcapone Subjects who are participating in any other clinical study
Gender	Both
Ages	30 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00537017
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	P05175, Preladenant;, Privadenant
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP