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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00537017
First received: September 27, 2007
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Enrollment: 140
Study Start Date: November 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCH 420814, 5 mg BID Drug: SCH 420814
SCH 420814, 5 mg BID
Other Name: Preladenant

  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: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00537017     History of Changes
Other Study ID Numbers: P05175, Preladenant;, Privadenant
Study First Received: September 27, 2007
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
 Parkinson Disease
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases

ClinicalTrials.gov processed this record on May 19, 2013