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Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593736
First Posted: January 15, 2008
Last Update Posted: February 28, 2012
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.
Information provided by (Responsible Party):
Takeda
Results First Submitted: July 31, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Sleep Disorders, Circadian Rhythm
Interventions: Drug: Ramelteon
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects enrolled at 47 sites in the United States from 10 October 2007 to 23 May 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened for 14 days, entered a 7-day placebo run-in, and then were randomized to once-daily (QD) treatment. To enter the double-blind randomization period, subjects must have met the eligible inclusion and none of the exclusion criteria and met sleep diagnostic criteria established during screening polysomnography.

Reporting Groups
  Description
Ramelteon 1 mg QD Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg QD Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg QD Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Placebo QD Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.

Participant Flow for 2 periods

Period 1:   Screening Period and Placebo Run-in
    Ramelteon 1 mg QD   Ramelteon 4 mg QD   Ramelteon 8 mg QD   Placebo QD
STARTED   0   0   0   549 
COMPLETED   0   0   0   132 
NOT COMPLETED   0   0   0   417 
Adverse Event                0                0                0                3 
Lost to Follow-up                0                0                0                9 
Withdrawal by Subject                0                0                0                43 
Study Termination                0                0                0                15 
Did Not Meet Criteria                0                0                0                322 
Various                0                0                0                25 

Period 2:   Treatment Period and Placebo Run-out
    Ramelteon 1 mg QD   Ramelteon 4 mg QD   Ramelteon 8 mg QD   Placebo QD
STARTED   32   33   35   32 
COMPLETED   29   31   30   28 
NOT COMPLETED   3   2   5   4 
Lost to Follow-up                2                1                2                0 
Protocol Violation                0                0                1                1 
Withdrawal by Subject                0                0                1                3 
Various                1                1                1                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.
No text entered.

Reporting Groups
  Description
Ramelteon 1 mg QD Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg QD Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg QD Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Placebo QD Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Total Total of all reporting groups

Baseline Measures
   Ramelteon 1 mg QD   Ramelteon 4 mg QD   Ramelteon 8 mg QD   Placebo QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   33   35   32   132 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.6  (9.36)   33.7  (12.31)   29.3  (9.40)   33.1  (13.08)   31.4  (11.19) 
Gender 
[Units: Subjects]
         
Female   18   17   17   12   64 
Male   14   16   18   20   68 
Ethnicity (NIH/OMB) 
[Units: Subjects]
         
Hispanic or Latino   19   19   19   18   75 
Not Hispanic or Latino   13   14   16   14   57 
Unknown or Not Reported   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Subjects]
         
American Indian or Alaska Native   1   0   0   0   1 
Asian   2   0   0   0   2 
Native Hawaiian or Other Pacific Islander   0   0   0   1   1 
Black or African American   4   3   3   3   13 
White   24   30   32   28   114 
More than one race   0   0   0   0   0 
Unknown or Not Reported   1   0   0   0   1 
Pharmacologic sleep aid needed to sleep [1] 
[Units: Subjects]
         
 31   30   33   32   126 
 0   0   1   0   1 
 0   2   1   0   3 
 1   1   0   0   2 
 0   0   0   0   0 
>4   0   0   0   0   0 
[1] For the question, "Do you use of pharmacological assistance to sleep," an answer of 'no'=0 and 'yes' resulted in the question, "If yes, how often per week?" 1=1 day/week; 2=2 days/week; 3=3 days/week; 4=4 days/week; >4=more than 4 days/week.
Time asleep (habitual and desired) 
[Units: Minutes]
Mean (Standard Deviation)
         
Habitual   368.0  (89.27)   406.4  (105.29)   371.6  (95.29)   384.8  (78.88)   382.6  (93.01) 
Desired   341.7  (76.46)   347.7  (72.05)   331.3  (75.30)   330.9  (64.43)   337.8  (72.06) 
Time to fall asleep (habitual and desired) [1] 
[Units: Minutes]
Mean (Standard Deviation)
         
Habitual   83.0  (78.85)   76.8  (59.89)   90.4  (64.79)   69.8  (58.72)   80.2  (65.66) 
Desired   167.5  (53.25)   164.4  (51.43)   165.0  (48.94)   155.0  (55.61)   163.0  (51.89) 
[1] Habitual sleep time defined as the time it takes to fall asleep starting at subject’s usual, later sleep time. Desired sleep time defined as the time it takes to fall asleep at subject’s preferred, earlier sleep time.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)   [ Time Frame: Nights 6-7 ]

2.  Secondary:   Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)   [ Time Frame: Nights 13-14 ]

3.  Secondary:   Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)   [ Time Frame: Nights 6-7 ]

4.  Secondary:   Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)   [ Time Frame: Nights 13-14 ]

5.  Secondary:   Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7)   [ Time Frame: Nights 6-7 ]

6.  Secondary:   Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14)   [ Time Frame: Nights 13-14 ]

7.  Secondary:   Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7)   [ Time Frame: Nights 6-7 ]

8.  Secondary:   Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14)   [ Time Frame: Nights 13-14 ]

9.  Secondary:   Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7)   [ Time Frame: Nights 6-7 ]

10.  Secondary:   Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14)   [ Time Frame: Nights 13-14 ]

11.  Secondary:   Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7)   [ Time Frame: Nights 6-7 ]

12.  Secondary:   Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14)   [ Time Frame: Nights 13-14 ]

13.  Secondary:   Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)   [ Time Frame: Nights 6-7 ]

14.  Secondary:   Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)   [ Time Frame: Nights 13-14 ]

15.  Secondary:   Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)   [ Time Frame: Nights 6-7 ]

16.  Secondary:   Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)   [ Time Frame: Nights 13-14 ]

17.  Secondary:   Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)   [ Time Frame: Nights 6-7 ]

18.  Secondary:   Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)   [ Time Frame: Nights 13-14 ]

19.  Secondary:   Total Sleep Time Measured by Actigraphy (Nights 6-7)   [ Time Frame: Nights 6-7 ]

20.  Secondary:   Total Sleep Time Measured by Actigraphy (Nights 13-14)   [ Time Frame: Nights 13-14 ]

21.  Secondary:   Sleep Efficiency Measured by Actigraphy (Nights 6-7)   [ Time Frame: Nights 6-7 ]

22.  Secondary:   Sleep Efficiency Measured by Actigraphy (Nights 13-14)   [ Time Frame: Nights 13-14 ]

23.  Secondary:   Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7)   [ Time Frame: Nights 6-7 ]

24.  Secondary:   Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14)   [ Time Frame: Nights 13-14 ]

25.  Secondary:   Wake Bouts Measured by Actigraphy (Nights 6-7)   [ Time Frame: Nights 6-7 ]

26.  Secondary:   Wake Bouts Measured by Actigraphy (Nights 13-14)   [ Time Frame: Nights 13-14 ]

27.  Secondary:   Sleep Latency Measured by Actigraphy (Nights 6-7)   [ Time Frame: Nights 6-7 ]

28.  Secondary:   Sleep Latency Measured by Actigraphy (Nights 13-14)   [ Time Frame: Nights 13-14 ]

29.  Secondary:   Sleep Time Measured by Actigraphy (Nights 6-7)   [ Time Frame: Nights 6-7 ]

30.  Secondary:   Sleep Time Measured by Actigraphy (Nights 13-14)   [ Time Frame: Nights 13-14 ]

31.  Secondary:   Wake Time Measured by Actigraphy (Nights 6-7)   [ Time Frame: Nights 6-7 ]

32.  Secondary:   Wake Time Measured by Actigraphy (Nights 13-14)   [ Time Frame: Nights 13-14 ]

33.  Secondary:   Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7)   [ Time Frame: Nights 6-7 ]

34.  Secondary:   Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14)   [ Time Frame: Nights 13-14 ]

35.  Secondary:   Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)   [ Time Frame: Nights 6-7 ]

36.  Secondary:   Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)   [ Time Frame: Nights 13-14 ]

37.  Secondary:   Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7)   [ Time Frame: Nights 6-7 ]

38.  Secondary:   Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14)   [ Time Frame: Nights 13-14 ]

39.  Secondary:   Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7)   [ Time Frame: Nights 6-7 ]

40.  Secondary:   Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14)   [ Time Frame: Nights 13-14 ]

41.  Secondary:   Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7)   [ Time Frame: Nights 6-7 ]

42.  Secondary:   Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14)   [ Time Frame: Nights 13-14 ]

43.  Secondary:   Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)   [ Time Frame: Nights 6-7 ]

44.  Secondary:   Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)   [ Time Frame: Nights 13-14 ]

45.  Secondary:   Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)   [ Time Frame: Nights 6-7 ]

46.  Secondary:   Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)   [ Time Frame: Nights 13-14 ]

47.  Secondary:   Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)   [ Time Frame: Nights 6-7 ]

48.  Secondary:   Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)   [ Time Frame: Nights 13-14 ]

49.  Secondary:   Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7)   [ Time Frame: Nights 6-7 ]

50.  Secondary:   Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14)   [ Time Frame: Nights 13-14 ]

51.  Secondary:   Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test   [ Time Frame: Day 15 ]

52.  Secondary:   Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate   [ Time Frame: Day 15 ]

53.  Secondary:   Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed   [ Time Frame: Day 15 ]

54.  Secondary:   Visual Analogue Scale for Mood   [ Time Frame: Day 15 ]

55.  Secondary:   Visual Analogue Scale for Feelings   [ Time Frame: Day 15 ]

56.  Secondary:   The Time of Dim Light Melatonin Secretion Onset   [ Time Frame: Day 15 ]

57.  Secondary:   The Time of Dim Light Melatonin Secretion Offset   [ Time Frame: Day 15 ]

58.  Secondary:   The Total Duration of Secretion of Melatonin   [ Time Frame: Day 15 ]

59.  Secondary:   The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours   [ Time Frame: Day 15 ]

60.  Secondary:   Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period.   [ Time Frame: Day 15 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00593736     History of Changes
Other Study ID Numbers: 01-04-TL-375-044
First Submitted: January 2, 2008
First Posted: January 15, 2008
Results First Submitted: July 31, 2009
Results First Posted: March 9, 2010
Last Update Posted: February 28, 2012



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