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

Sponsor:	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

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)

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Brain Diseases Degenerative Nerve Diseases Movement Disorders Neurologic Diseases Parkinson's Disease

Drug Information available for: Sch 420814

U.S. FDA Resources

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:	November 2009
Estimated Primary Completion Date:	November 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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05175, Preladenant;, Privadenant
Study First Received:	September 27, 2007
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00537017 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Parkinson Disease
Movement Disorders
Basal Ganglia Diseases
Nervous System Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on November 05, 2009