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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: October 11, 2016
Last verified: September 2016
Results First Received: October 11, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Parkinson Disease
Neurodegenerative Diseases
Central Nervous System Diseases
Movement Disorders
Brain Diseases
Interventions: Drug: Preladenant
Drug: L-dopa
Drug: Other Parkinson's Disease treatments

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants from Study P04501 (NCT00406029) were enrolled into this study (Treatment Phase [TP] and Follow-up Phase [FUP]).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for entry into the TP was performed over an 8 day period.

Reporting Groups
  Description
Preladenant 5 mg BID Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.

Participant Flow for 2 periods

Period 1:   Treatment Phase
    Preladenant 5 mg BID
STARTED   140 
COMPLETED   106 
NOT COMPLETED   34 
Adverse Event                19 
Withdrawal by Subject                13 
Protocol Violation                2 

Period 2:   Follow-up Phase
    Preladenant 5 mg BID
STARTED   135 [1] 
COMPLETED   126 
NOT COMPLETED   9 
Withdrawal by Subject                9 
[1] All TP participants were eligible for FUP entry. 5 participants completing TP did not enter FUP.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Preladenant 5 mg BID Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.

Baseline Measures
   Preladenant 5 mg BID 
Overall Participants Analyzed 
[Units: Participants]
 140 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.9  (9.8) 
Gender 
[Units: Participants]
 
Female   45 
Male   95 


  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced at Least One Adverse Event   [ Time Frame: Up to 42 weeks ]

2.  Secondary:   Time Spent in "Off" State Per Day   [ Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 ]

3.  Secondary:   Awake Time Per Day in the "on" State   [ Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 ]

4.  Secondary:   Time Spent in the "on" State With no Dyskinesias   [ Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 ]

5.  Secondary:   Time Spent in the "on" State With Troublesome Dyskinesias   [ Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 ]

6.  Secondary:   Time Spent in the "on" State Without Troublesome Dyskinesia   [ Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 ]

7.  Secondary:   Absolute Duration of Dyskinesias   [ Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 ]

8.  Secondary:   Total Sleep Time   [ Time Frame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00537017     History of Changes
Other Study ID Numbers: P05175
MK-3814-021 ( Other Identifier: Merck )
Study First Received: September 27, 2007
Results First Received: October 11, 2016
Last Updated: October 11, 2016
Health Authority: United States: Food and Drug Administration