Trial · NCT04549168
A Study of Lemborexant in Chinese Participants With Insomnia Disorder
NCT04549168, Phase 3, Completed, Eisai Co., Ltd.; results first posted 2024-12-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Lemborexant in Chinese Participants With Insomnia Disorder. Trials, record NCT04549168. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04549168
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Lemborexant in Chinese Participants With Insomnia Disorder
- NCT number
- NCT04549168
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 194 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Sleep Initiation and Maintenance Disorders
- Interventions
- Lemborexant, Placebo
- First posted
- 2020-09-16
- Last updated
- 2024-12-20
- Results first posted
- 2024-12-20
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of Mean Latency to Persistent Sleep (LPS) Over the Last 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Days 29 and 30 | LPS was defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by polysomnography (PSG). Change from baseline to average LPS on Days 29 and 30 was reported. The outcome measure was planned to be assessed for randomization phase only. |
| Secondary | Change From Baseline of Mean Objective Sleep Efficiency (SE) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Days 29 and 30 | SE was defined as percentage (%) of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG multiplied by 100. Change from baseline to average SE on Days 29 and 30 was reported. The outcome measure was planned to be assessed for randomization phase only. |
| Secondary | Change From Baseline in Mean Objective Wake After Sleep Onset (WASO) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Days 29 and 30 | WASO was defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Days 29 and 30 was reported. The outcome measure was planned to be assessed for randomization phase only. |
| Secondary | Change From Baseline of Subjective Sleep Onset Latency (sSOL) Over the Last 7 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 24 to 30 | sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. Change from baseline to average sSOL of Nights 24 to 30 was reported. The outcome measure was planned to be assessed for randomization phase only. |
| Secondary | Change From Baseline of Subjective Sleep Efficiency (sSE) Over the Last 7 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 24 to 30 | sSE was defined as percentage of subjective total sleep time (sTST) divided by subjective time spent in bed, calculated as the interval from the time the participant reported attempting to sleep until the time participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus subjective wake after sleep onset (sWASO). WASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. Change from baseline to average sSE of Nights 24 to 30 was reported. The outcome measure was planned to be assessed for randomization phase only. |
| Secondary | Change From Baseline in Subjective Wake After Sleep Onset Over the Last 7 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 24 to 30 | sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. Change from baseline to average sWASO of Nights 24 to 30 was reported. The outcome measure was planned to be assessed for randomization phase only. |
| Secondary | Change From Baseline of Mean Latency to Persistent Sleep Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 1 and 2 | LPS was defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by polysomnography. Change from baseline to average LPS on Nights 1 and 2 was reported. The outcome measure was planned to be assessed for randomization phase only. |
| Secondary | Change From Baseline of Mean Sleep Efficiency Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 1 and 2 | SE was defined as percentage of time spent in bed asleep, calculated as total sleep time divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Nights 1 and 2 was reported. The outcome measure was planned to be assessed for randomization phase only. |
| Secondary | Change From Baseline of Mean Wake After Sleep Onset Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 1 and 2 | WASO was defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Nights 1 and 2 was reported. The outcome measure was planned to be assessed for randomization phase only. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of study drug up to 44 days | A TEAE was defined as an AE with onset date on or after the first dose of study drug up to 14 days after the last dose of study drug. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening (that is, participant was at immediate risk of death from AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). The outcome measure was planned to be assessed for randomization phase only. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline of Mean Latency to Persistent Sleep (LPS) Over the Last 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Days 29 and 30 | The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | minutes | MEAN |
| SECONDARY | Change From Baseline of Mean Objective Sleep Efficiency (SE) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Days 29 and 30 | The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | % time (minutes) in bed asleep | MEAN |
| SECONDARY | Change From Baseline in Mean Objective Wake After Sleep Onset (WASO) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Days 29 and 30 | The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | minutes | MEAN |
| SECONDARY | Change From Baseline of Subjective Sleep Onset Latency (sSOL) Over the Last 7 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 24 to 30 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | minutes | MEAN |
| SECONDARY | Change From Baseline of Subjective Sleep Efficiency (sSE) Over the Last 7 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 24 to 30 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | % of time (minutes) in bed asleep | MEAN |
| SECONDARY | Change From Baseline in Subjective Wake After Sleep Onset Over the Last 7 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 24 to 30 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | minutes | MEAN |
| SECONDARY | Change From Baseline of Mean Latency to Persistent Sleep Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 1 and 2 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. | minutes | MEAN |
| SECONDARY | Change From Baseline of Mean Sleep Efficiency Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 1 and 2 | The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement. | % of time (minutes) in bed asleep | MEAN |
| SECONDARY | Change From Baseline of Mean Wake After Sleep Onset Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Baseline, Nights 1 and 2 | The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement. | minutes | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of study drug up to 44 days | The safety analysis set was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline of Mean Latency to Persistent Sleep (LPS) Over the Last 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Randomization Phase: Placebo | -21.71 | Standard Deviation 42.809 | minutes | |
| Change From Baseline of Mean Latency to Persistent Sleep (LPS) Over the Last 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Randomization Phase: Lemborexant 10 mg | -39.47 | Standard Deviation 46.147 | minutes | |
| Change From Baseline of Mean Objective Sleep Efficiency (SE) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Randomization Phase: Placebo | 7.40 | Standard Deviation 12.853 | % time (minutes) in bed asleep | |
| Change From Baseline of Mean Objective Sleep Efficiency (SE) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Randomization Phase: Lemborexant 10 mg | 15.33 | Standard Deviation 11.124 | % time (minutes) in bed asleep | |
| Change From Baseline in Mean Objective Wake After Sleep Onset (WASO) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Randomization Phase: Placebo | -14.30 | Standard Deviation 42.733 | minutes | |
| Change From Baseline in Mean Objective Wake After Sleep Onset (WASO) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Randomization Phase: Lemborexant 10 mg | -36.65 | Standard Deviation 35.342 | minutes | |
| Change From Baseline of Subjective Sleep Onset Latency (sSOL) Over the Last 7 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Randomization Phase: Placebo | -22.41 | Standard Deviation 32.183 | minutes | |
| Change From Baseline of Subjective Sleep Onset Latency (sSOL) Over the Last 7 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo | Randomization Phase: Lemborexant 10 mg | -33.10 | Standard Deviation 50.060 | minutes | |
| Change From Baseline of Subjective Sleep Efficiency (sSE) Over the Last 7 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Randomization Phase: Placebo | 8.88 | Standard Deviation 11.630 | % of time (minutes) in bed asleep | |
| Change From Baseline of Subjective Sleep Efficiency (sSE) Over the Last 7 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo | Randomization Phase: Lemborexant 10 mg | 13.16 | Standard Deviation 16.559 | % of time (minutes) in bed asleep |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Prerandomization Phase | STARTED | Prerandomization Phase: All Participants | 194 | |
| Prerandomization Phase | STARTED | Randomization Phase: Placebo | 0 | |
| Prerandomization Phase | STARTED | Randomization Phase: Lemborexant 10 mg | 0 | |
| Prerandomization Phase | COMPLETED | Prerandomization Phase: All Participants | 194 | |
| Prerandomization Phase | COMPLETED | Randomization Phase: Placebo | 0 | |
| Prerandomization Phase | COMPLETED | Randomization Phase: Lemborexant 10 mg | 0 | |
| Prerandomization Phase | NOT COMPLETED | Prerandomization Phase: All Participants | 0 | |
| Prerandomization Phase | NOT COMPLETED | Randomization Phase: Placebo | 0 | |
| Prerandomization Phase | NOT COMPLETED | Randomization Phase: Lemborexant 10 mg | 0 | |
| Randomization Phase | STARTED | Prerandomization Phase: All Participants | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events186
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Prerandomization Phase: All Participants | 0 | 194 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Randomization Phase: Placebo | 2 | 100 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Randomization Phase: Lemborexant 10 mg | 0 | 94 | |
| other | Anaemia | Blood and lymphatic system disorders | Prerandomization Phase: All Participants | 1 | 194 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomization Phase: Placebo | 0 | 100 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomization Phase: Lemborexant 10 mg | 1 | 94 | |
| other | Atrial tachycardia | Cardiac disorders | Prerandomization Phase: All Participants | 0 | 194 | |
| other | Atrial tachycardia | Cardiac disorders | Randomization Phase: Placebo | 0 | 100 | |
| other | Atrial tachycardia | Cardiac disorders | Randomization Phase: Lemborexant 10 mg | 1 | 94 | |
| other | Sinus bradycardia | Cardiac disorders | Prerandomization Phase: All Participants | 0 | 194 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prerandomization Phase: All Participants | 0 | 194 |
| Total, all-cause mortality | Randomization Phase: Placebo | 0 | 100 |
| Total, all-cause mortality | Randomization Phase: Lemborexant 10 mg | 0 | 94 |
| Total, other adverse events | Prerandomization Phase: All Participants | 19 | 194 |
| Total, other adverse events | Randomization Phase: Placebo | 20 | 100 |
| Total, other adverse events | Randomization Phase: Lemborexant 10 mg | 30 | 94 |
| Total, serious adverse events | Prerandomization Phase: All Participants | 0 | 194 |
| Total, serious adverse events | Randomization Phase: Placebo | 1 | 100 |
| Total, serious adverse events | Randomization Phase: Lemborexant 10 mg | 0 | 94 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41442783 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04549168
GET https://conductscience.org/api/trials/v1/NCT04549168/results?page=2