Trial record 1 of 1 for:    NCT01155479
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A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664) (PARADYSE)

This study has been terminated.
(Termininated for business reasons)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01155479
First received: June 30, 2010
Last updated: June 15, 2016
Last verified: June 2016
Results First Received: June 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
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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 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
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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 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  
Number of Participants  
[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)  
Gender  
[units: Participants]
           
Female     78     90     90     82     85     425  
Male     126     114     116     122     119     597  



  Outcome Measures
  Show All 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 ]

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

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

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

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

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

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


  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



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 )
Study First Received: June 30, 2010
Results First Received: June 15, 2016
Last Updated: June 15, 2016
Health Authority: United States: Food and Drug Administration