Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175) - Full Text View

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

U.S. FDA Resources

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)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Proportion of subjects reporting AEs [ Time Frame: 36 weeks of open-label treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537017

Contacts


Contact: SP Clinical Trial Registry Call Center	1-888-772-8734

Locations


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

Sponsors and Collaborators

Schering-Plough

Investigators


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

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 August 29, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00537017