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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00537017
First received: September 27, 2007
Last updated: February 28, 2014
Last verified: February 2014

September 27, 2007
February 28, 2014
November 2007
November 2009   (final data collection date for primary outcome measure)
Proportion of subjects reporting AEs [ Time Frame: 36 weeks of open-label treatment ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00537017 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)
A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 5 mg BID (Protocol No. P05175)

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."

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Parkinson Disease
  • Neurodegenerative Diseases
  • Central Nervous System Diseases
  • Movement Disorders
  • Brain Diseases
Drug: SCH 420814
SCH 420814, 5 mg BID
Other Name: Preladenant
Experimental: SCH 420814, 5 mg BID
Intervention: Drug: SCH 420814
Factor SA, Wolski K, Togasaki DM, Huyck S, Cantillon M, Ho TW, Hauser RA, Pourcher E. Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease. Mov Disord. 2013 Jun;28(6):817-20. doi: 10.1002/mds.25395. Epub 2013 Apr 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00537017
P05175, Preladenant;, Privadenant
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP