Phase 3
Completed N=488
Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia
Sleep Initiation and Maintenance Disorders
Source: ClinicalTrials.gov NCT00756002 ↗
Enrolled (actual)
488
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcomePrimary: Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2). — 67.0; 41.7 minutes — p=<0.001
Summary
The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once daily (QD), in subjects with chronic insomnia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2). |
67.0; 41.7 | <0.001 sig |
| SECONDARY Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16). |
65.3; 39.2 | <0.001 sig |
| SECONDARY Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30). |
60.5; 37.2 | <0.001 sig |
| SECONDARY Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2). |
73.5; 61.5 | 0.003 sig |
| SECONDARY Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16). |
72.3; 55.8 | <0.001 sig |
| SECONDARY Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30). |
72.3; 53.7 | <0.001 sig |
| SECONDARY Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2). |
69.9; 52.7 | <0.001 sig |
| SECONDARY Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4). |
65.7; 51.0 | <0.001 sig |
| SECONDARY Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5). |
67.4; 50.4 | <0.001 sig |
| SECONDARY Total Sleep Time, Per Polysomnography (Nights 1-2). |
356.5; 381.1 | <0.001 sig |
| SECONDARY Total Sleep Time, Per Polysomnography (Nights 15-16). |
357.0; 380.3 | <0.001 sig |
| SECONDARY Total Sleep Time, Per Polysomnography (Nights 29-30). |
361.7; 386.2 | <0.001 sig |
| SECONDARY Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 1-2). |
330.6; 347.0 | <0.001 sig |
| SECONDARY Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 15-16). |
332.6; 345.9 | 0.043 sig |
| SECONDARY Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 29-30). |
335.0; 355.3 | 0.005 sig |
| SECONDARY Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 2). |
343.7; 357.1 | 0.010 sig |
| SECONDARY Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 4). |
349.4; 366.7 | 0.002 sig |
| SECONDARY Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 5). |
350.7; 366.1 | 0.006 sig |
| SECONDARY Sleep Efficiency, Per Polysomnography (Nights 1-2). |
74.3; 79.5 | <0.001 sig |
| SECONDARY Sleep Efficiency, Per Polysomnography (Nights 15-16). |
74.5; 79.4 | <0.001 sig |
| SECONDARY Sleep Efficiency, Per Polysomnography (Nights 29-30). |
75.6; 80.5 | <0.001 sig |
| SECONDARY Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 1-2). |
4.4; 4.1 | <0.001 sig |
| SECONDARY Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 15-16). |
4.3; 3.9 | <0.001 sig |
| SECONDARY Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 29-30). |
4.2; 3.7 | <0.001 sig |
| SECONDARY Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 2). |
4.2; 3.8 | <0.001 sig |
| SECONDARY Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 4). |
4.1; 3.7 | <0.001 sig |
| SECONDARY Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 5). |
4.1; 3.7 | <0.001 sig |
| SECONDARY Wake Time After Sleep Onset, Per Polysomnography (Nights 1-2). |
61.1; 62.2 | 0.785 |
| SECONDARY Wake Time After Sleep Onset, Per Polysomnography (Nights 15-16). |
62.6; 66.1 | 0.422 |
| SECONDARY Wake Time After Sleep Onset, Per Polysomnography (Nights 29-30). |
62.4; 60.3 | 0.665 |
| SECONDARY Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 1-2). |
82.2; 76.3 | 0.228 |
| SECONDARY Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 15-16). |
83.8; 74.5 | 0.099 |
| SECONDARY Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 29-30). |
81.1; 63.8 | 0.005 sig |
| SECONDARY Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 2). |
70.8; 59.8 | 0.004 sig |
| SECONDARY Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 4). |
65.8; 52.5 | 0.001 sig |
| SECONDARY Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 5). |
67.7; 55.7 | 0.004 sig |
| SECONDARY Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2). |
9.6; 10.4 | 0.040 sig |
| SECONDARY Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16). |
9.9; 9.7 | 0.814 |
| SECONDARY Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30). |
9.8; 9.7 | 0.929 |
| SECONDARY Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 1-2). |
2.9; 2.8 | 0.591 |
| SECONDARY Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 15-16). |
3.0; 2.6 | 0.015 sig |
| SECONDARY Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 29-30). |
2.8; 2.5 | 0.097 |
| SECONDARY Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 2). |
2.2; 2.0 | 0.028 sig |
| SECONDARY Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 4). |
2.2; 1.8 | 0.003 sig |
| SECONDARY Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 5). |
2.3; 2.1 | 0.111 |
Eligibility Criteria
Inclusion Criteria
- A female subject of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study.
- Has a body mass index between 18 and 34, inclusive.
- Based on sleep history, the subject has had chronic insomnia for at least 3 months, as defined by the following:
- The predominant complaint is difficulty initiating or maintaining sleep, or non-restorative sleep, for at least 3 months.
- The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
- The sleep disturbance does not occur exclusively during the course of narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, or parasomnia.
- The disturbance does not occur exclusively during the course of another mental disorder (eg, major depressive disorder, generalized anxiety disorder, delirium).
- The disturbance is not due to the direct physiological effects of a substance or a general medical condition.
- Based on sleep history, the subject reports a history of subjective sleep latency ≥45 minutes and a subjective total sleep time ≤6.5 hours for at least 3 months.
- Based on sleep history, the subject's habitual bedtime is between 10:00 PM and 1:00 AM.
- On at least 3 of the first 5 nights of single blind run-in placebo treatment, the subject must have an subjective sleep latency of ≥45 minutes and a subjective total sleep time of 30 minutes from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the first week of single-blind run-in.
- a difference in average subjective sleep latency >30 minutes from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the second week of single-blind run-in.
- a difference in average subjective sleep latency >30 minutes from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the third week of single-blind run-in.
- Has periodic leg movements during sleep with arousal index (per hour of sleep) >10 as seen on polysomnography on the first night of polysomnography screening.
- Has any additional condition(s) that in the Investigator's opinion would:
- Affect sleep/wake function
- Prohibit the subject from completing the study
- Not be in the best interest of the subject to complete the study.
Data sourced from ClinicalTrials.gov (NCT00756002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.