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Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01227265
First received: October 22, 2010
Last updated: March 14, 2016
Last verified: March 2016
Results First Received: March 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Parkinson Disease
Idiopathic Parkinson Disease
Idiopathic Parkinson's Disease
Interventions: Drug: Preladenant
Drug: Placebo

  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
Adult participants with a diagnosis of moderate to severe idiopathic Parkinson's disease were selected to participate in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a Screening Period of up to 5 weeks, participants were randomized into 1 of 3 treatment groups (preladenant 2 or 5 mg twice daily or placebo) for 12 weeks. At the end of treatment, participants could choose to enter into an extension trial or return for a follow-up visit 2 weeks later.

Reporting Groups
  Description
Preladenant 2 mg Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
Preladenant 5 mg Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
Placebo Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.

Participant Flow:   Overall Study
    Preladenant 2 mg     Preladenant 5 mg     Placebo  
STARTED     158     159     159  
Treated     157     157     159  
COMPLETED     139     139     145  
NOT COMPLETED     19     20     14  
Did Not Receive Treatment                 1                 2                 0  
Administrative                 1                 0                 2  
Did Not Meet Protocol Eligibility                 0                 0                 1  
Protocol Violation                 2                 1                 0  
Withdrawal by Subject                 7                 7                 3  
Lost to Follow-up                 2                 0                 3  
Adverse Event                 6                 10                 5  



  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.
All Participants as Treated - all participants who received at least one dose of study drug

Reporting Groups
  Description
Preladenant 2 mg Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
Preladenant 5 mg Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
Placebo Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
Total Total of all reporting groups

Baseline Measures
    Preladenant 2 mg     Preladenant 5 mg     Placebo     Total  
Number of Participants  
[units: participants]
  157     157     159     473  
Age  
[units: Years]
Mean (Standard Deviation)
  62.9  (9.0)     64.2  (8.7)     64.2  (8.9)     63.8  (8.9)  
Gender  
[units: Participants]
       
Female     49     71     64     184  
Male     108     86     95     289  



  Outcome Measures
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1.  Primary:   Change From Baseline in Average "Off" Time (Hours Per Day) at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Primary:   Number of Participants With Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg Increase   [ Time Frame: Up to Week 14 ]

3.  Primary:   Number of Participants With Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg Increase   [ Time Frame: Up to Week 14 ]

4.  Primary:   Percentage of Participants With Suicidality   [ Time Frame: Up to Week 12 ]

5.  Primary:   Change From Baseline in Total Epworth Sleepiness Scale (ESS) at Week 12   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean "Off" Time   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Change From Baseline in Average "On" Time (Hours Per Day) Without Troublesome Dyskinesia at Week 12   [ Time Frame: Baseline and Week 12 ]


  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: NCT01227265     History of Changes
Other Study ID Numbers: P07037
2010-020112-11 ( EudraCT Number )
MK-3814-028 ( Other Identifier: Merck Study Number )
Study First Received: October 22, 2010
Results First Received: March 14, 2016
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration