ClinicalTrials.gov
ClinicalTrials.gov Menu

A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664) (PARADYSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01155479
Recruitment Status : Terminated (Termininated for business reasons)
First Posted : July 1, 2010
Results First Posted : July 28, 2016
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Drug: Preladenant 2 mg tablet
Drug: Preladenant 5 mg tablet
Drug: Preladenant 10 mg tablet
Drug: Rasagiline 1 mg capsule
Drug: Placebo for Rasagiline 1 mg capsule
Drug: Placebo for Preladenant

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with a diagnosis of idiopathic PD for less than 5 years 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
In Part 1, participants were randomized to one of five treatment groups and treated for 26 weeks. In Part 2, which was conducted for an additional 26 weeks, participants continued taking the same study treatment from Part 1, except for placebo participants who were re-assigned to receive preladenant 5 mg twice daily.

Reporting Groups
  Description
Preladenant 2 mg Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Preladenant 5 mg Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Preladenant 10 mg Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Placebo Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
Rasagiline Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

Participant Flow for 2 periods

 Period 1:   Part I
    Preladenant 2 mg   Preladenant 5 mg   Preladenant 10 mg   Placebo   Rasagiline
STARTED   204   204   206   204   204 
Treated   200   202   204   198   203 
COMPLETED   166   177   167   177   181 
NOT COMPLETED   38   27   39   27   23 
Adverse Event                13                8                18                7                6 
Administrative                2                2                2                0                0 
Did Not Meet Protocol Eligibility                3                1                2                1                3 
Withdrawal by Subject                11                13                8                8                9 
Lost to Follow-up                0                0                1                1                0 
Treatment Failure                3                0                3                1                2 
Did Not Receive Treatment                4                2                2                6                1 
Non-Compliance with Protocol                2                1                3                3                2 

Period 2:   Part II
    Preladenant 2 mg   Preladenant 5 mg   Preladenant 10 mg   Placebo   Rasagiline
STARTED   166   177   167   177   181 
COMPLETED   107   116   109   127   126 
NOT COMPLETED   59   61   58   50   55 
Adverse Event                7                6                8                3                4 
Administrative                43                49                36                38                46 
Withdrawal by Subject                8                4                12                7                3 
Lost to Follow-up                1                0                0                0                1 
Treatment Failure                0                1                2                0                1 
Non-Compliance with Protocol                0                1                0                2                0 



  Baseline Characteristics

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 Randomized

Reporting Groups
  Description
Preladenant 2 mg Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Preladenant 5 mg Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Preladenant 10 mg Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Placebo Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
Rasagiline Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Total Total of all reporting groups

Baseline Measures
   Preladenant 2 mg   Preladenant 5 mg   Preladenant 10 mg   Placebo   Rasagiline   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 204   204   206   204   204   1022 
Age 
[Units: Years]
Mean (Standard Deviation) 		 63.0  (10.5)   62.3  (10.2)   63.8  (11.1)   63.3  (10.0)   62.9  (10.2)   63.1  (10.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		           
Female      78  38.2%      90  44.1%      90  43.7%      82  40.2%      85  41.7%      425  41.6% 
Male      126  61.8%      114  55.9%      116  56.3%      122  59.8%      119  58.3%      597  58.4% 


  Outcome Measures

1.  Primary:   Change From Baseline in the Sum of Unified Parkinson’s Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3)   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Adverse Events (AEs) in Part 1   [ Time Frame: Day 1 to Week 26 ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants Who Discontinued Study Due to an AE in Part 1   [ Time Frame: Day 1 to Week 26 ]
  Show Outcome Measure 3

4.  Primary:   Number of Participants With Adverse Events (AEs) in Part 2   [ Time Frame: Week 27 to Week 52 ]
  Show Outcome Measure 4

5.  Primary:   Number of Participants Who Discontinued Study Due to an AE in Part 2   [ Time Frame: Week 27 to Week 52 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3)   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL])   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 7


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: NCT01155479     History of Changes
Other Study ID Numbers: P05664
2009-013552-72 ( EudraCT Number )
MK-3814-024 ( Other Identifier: Merck Study Number )
First Submitted: June 30, 2010
First Posted: July 1, 2010
Results First Submitted: June 15, 2016
Results First Posted: July 28, 2016
Last Update Posted: September 29, 2017