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Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00792298
First received: November 10, 2008
Last updated: February 23, 2015
Last verified: February 2015
Results First Received: August 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Primary Insomnia
Interventions: Drug: Suvorexant
Drug: Dose-matched Placebo to Suvorexant

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Suvorexant 10 mg → Placebo After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
Placebo → Suvorexant 10 mg After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2.
Suvorexant 20 mg → Placebo After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
Placebo → Suvorexant 20 mg After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2.
Suvorexant 40 mg → Placebo After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
Placebo → Suvorexant 40 mg After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2.
Suvorexant 80 mg → Placebo After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
Placebo → Suvorexant 80 mg After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2.

Participant Flow for 3 periods

Period 1:   Treatment Period 1
    Suvorexant 10 mg → Placebo     Placebo → Suvorexant 10 mg     Suvorexant 20 mg → Placebo     Placebo → Suvorexant 20 mg     Suvorexant 40 mg → Placebo     Placebo → Suvorexant 40 mg     Suvorexant 80 mg → Placebo     Placebo → Suvorexant 80 mg  
STARTED     31     32     33     32     32     32     31     31  
COMPLETED     30     31     31     28     32     29     27     30  
NOT COMPLETED     1     1     2     4     0     3     4     1  
Adverse Event                 0                 1                 0                 1                 0                 1                 1                 0  
Lack of Efficacy                 0                 0                 1                 0                 0                 0                 0                 0  
Withdrawal by Subject                 1                 0                 1                 2                 0                 2                 1                 0  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 1                 0  
Physician Decision                 0                 0                 0                 1                 0                 0                 1                 0  
Protocol Violation                 0                 0                 0                 0                 0                 0                 0                 1  

Period 2:   Washout
    Suvorexant 10 mg → Placebo     Placebo → Suvorexant 10 mg     Suvorexant 20 mg → Placebo     Placebo → Suvorexant 20 mg     Suvorexant 40 mg → Placebo     Placebo → Suvorexant 40 mg     Suvorexant 80 mg → Placebo     Placebo → Suvorexant 80 mg  
STARTED     30     31     32 [1]   28     32     29     29 [2]   30  
COMPLETED     30     31     31     28     32     27     29     30  
NOT COMPLETED     0     0     1     0     0     2     0     0  
Adverse Event                 0                 0                 0                 0                 0                 1                 0                 0  
Withdrawal by Subject                 0                 0                 1                 0                 0                 1                 0                 0  
[1] 1 participant discontinued therapy during Period 1 but entered the Washout as allowed per protocol
[2] 2 participants discontinued therapy during Period 1 but entered the Washout as allowed per protocol

Period 3:   Treatment Period 2
    Suvorexant 10 mg → Placebo     Placebo → Suvorexant 10 mg     Suvorexant 20 mg → Placebo     Placebo → Suvorexant 20 mg     Suvorexant 40 mg → Placebo     Placebo → Suvorexant 40 mg     Suvorexant 80 mg → Placebo     Placebo → Suvorexant 80 mg  
STARTED     30     31     31     28     32     27     29     30  
COMPLETED     29     30     30     26     30     27     28     28  
NOT COMPLETED     1     1     1     2     2     0     1     2  
Lack of Efficacy                 0                 0                 0                 0                 1                 0                 0                 0  
Physician Decision                 0                 0                 0                 0                 0                 0                 1                 0  
Pregnancy                 0                 0                 1                 0                 0                 0                 0                 0  
Withdrawal by Subject                 1                 1                 0                 2                 1                 0                 0                 2  



  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.
No text entered.

Reporting Groups
  Description
All Treated Participants All randomized participants who received at least one dose of study treatment.

Baseline Measures
    All Treated Participants  
Number of Participants  
[units: participants]
  254  
Age  
[units: years]
Mean (Standard Deviation)
  44.4  (11.5)  
Gender  
[units: participants]
 
Female     148  
Male     106  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   LS Mean Sleep Efficiency (SE) During Periods 1 and 2   [ Time Frame: Night 1 and end of Week 4 ]

2.  Secondary:   LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2   [ Time Frame: Night 1 and end of Week 4 ]

3.  Secondary:   LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2   [ Time Frame: Night 1 and end of Week 4 ]

4.  Post-Hoc:   LS Mean Latency to the Onset of Persistent Sleep (LPS) During Period 1 (To Exclude Carryover Effect)   [ Time Frame: Night 1 (Period 1 only) and end of Week 4 (Period 1 only) ]


  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: NCT00792298     History of Changes
Other Study ID Numbers: 4305-006
2008_583 ( Other Identifier: Merck Registration Number )
Study First Received: November 10, 2008
Results First Received: August 19, 2014
Last Updated: February 23, 2015
Health Authority: United States: Food and Drug Administration