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Ramelteon for a Nap Prior to a Night Shift

This study has been completed.
Sponsor:
Collaborator:
Takeda Global Research & Development Center, Inc.
Information provided by (Responsible Party):
Elizabeth B. Klerman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00595075
First received: January 7, 2008
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
Results First Received: July 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Healthy
Interventions: Drug: Ramelteon
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
Healthy volunteers were recruited

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants received 1 dose of ramelteon or placebo during the first inpatient visit and then returned approximately four weeks later for the other condition, counterbalanced for order

Reporting Groups
  Description
Ramelteon in First Crossover Period Ramelteon 8 mg will be given prior to a 2-hour nap
Placebo in First Crossover Period Placebo will be given prior to a 2-hour nap

Participant Flow:   Overall Study
    Ramelteon in First Crossover Period     Placebo in First Crossover Period  
STARTED     6     5  
COMPLETED     5     5  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Ramelteon in First Crossover Period Ramelteon 8 mg will be given prior to a 2-hour nap
Placebo in First Crossover Period Placebo will be given prior to a 2-hour nap
Total Total of all reporting groups

Baseline Measures
    Ramelteon in First Crossover Period     Placebo in First Crossover Period     Total  
Number of Participants  
[units: participants]
 		  6     5     11  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     6     5     11  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  22.7  ± 4.1     26.8  ± 3.2     24.5  ± 4.1  
Gender  
[units: participants]
 		     
Female     2     4     6  
Male     4     1     5  
Region of Enrollment  
[units: participants]
 		     
United States     6     5     11  



  Outcome Measures
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1.  Primary:   Sleep Efficiency   [ Time Frame: 2 hours ]
  Show Outcome Measure 1

2.  Other Pre-specified:   Post-nap Assessment - Visual Analog Scale   [ Time Frame: 71 minutes ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Post Nap Assessment - Karolinska Sleepiness Scale   [ Time Frame: 71 minutes ]
  Show Outcome Measure 3

4.  Other Pre-specified:   Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers)   [ Time Frame: 71 minutes ]
  Show Outcome Measure 4

5.  Other Pre-specified:   Post Nap Assessment - Karolinska Drowsiness Test   [ Time Frame: 71 minutes ]
  Show Outcome Measure 5

6.  Other Pre-specified:   Psychomotor Vigilance Task - Median Reaction Time   [ Time Frame: 8 hours ]
  Show Outcome Measure 6

7.  Other Pre-specified:   Psychomotor Vigilance Task - Number of Lapses   [ Time Frame: 8 hours ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
Circadian phase was not measured.  


Results Point of Contact:  
Name/Title: Daniel Cohen
Organization: Sentara Neurology Specialists
phone: 757-388-6323
e-mail: dacohen@sentara.com


Publications of Results:


Responsible Party: Elizabeth B. Klerman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00595075     History of Changes
Other Study ID Numbers: Takeda - 103113
Study First Received: January 7, 2008
Results First Received: July 22, 2010
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board