Trial · NCT03001557
Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
NCT03001557, Phase 2, Completed, Eisai Inc.; results first posted 2020-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia. Trials, record NCT03001557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03001557
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
- NCT number
- NCT03001557
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Irregular Sleep-Wake Rhythm Disorder
- Interventions
- Lemborexant 2.5 mg, Lemborexant 5 mg, Lemborexant 10 mg, Lemborexant 15 mg, Lemborexant-matched placebo
- First posted
- 2016-12-23
- Last updated
- 2021-05-17
- Other registries' IDs
- eudract:2017-003306-40
- Results first posted
- 2020-01-14
Source ClinicalTrials.gov
Registered outcomes53
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Baseline, Week 1 | aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported. |
| Primary | Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 2 of Treatment | Baseline, Week 2 | aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported. |
| Primary | Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 3 of Treatment | Baseline, Week 3 | aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported. |
| Primary | Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 4 of Treatment | Baseline, Week 4 | aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported. |
| Primary | Core Phase: Change From Baseline in Mean Sleep Fragmentation Index (SFI) During Week 1 of Treatment | Baseline, Week 1 | The SFI was defined as the sum of a movement index (MI) and a fragmentation index (FI) during the logged sleep period. The MI was equal to the epochs of wake per time in bed (TBI) multiplied by 100. The FI was equal to the number of less than or equal to (\<=) 1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (%) (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported. |
| Primary | Core Phase: Change From Baseline in Mean SFI During Week 2 of Treatment | Baseline, Week 2 | The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number \<=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported. |
| Primary | Core Phase: Change From Baseline in Mean SFI During Week 3 of Treatment | Baseline, Week 3 | The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number \<=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported. |
| Primary | Core Phase: Change From Baseline in Mean SFI During Week 4 of Treatment | Baseline, Week 4 | The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number \<=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported. |
| Primary | Core Phase: Change From Baseline in the Mean Duration of Wake Bouts (aMeanDurWB) During Week 1 of Treatment | Baseline, Week 1 | aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported. |
| Primary | Core Phase: Change From Baseline in the aMeanDurWB During Week 2 of Treatment | Baseline, Week 2 | aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported. |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 registered outcomesOutcomes53
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Baseline, Week 1 | The full analysis set (FAS) included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of sleep time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 2 of Treatment | Baseline, Week 2 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of sleep time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 3 of Treatment | Baseline, Week 3 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of sleep time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 4 of Treatment | Baseline, Week 4 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of sleep time | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean Sleep Fragmentation Index (SFI) During Week 1 of Treatment | Baseline, Week 1 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean SFI During Week 2 of Treatment | Baseline, Week 2 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean SFI During Week 3 of Treatment | Baseline, Week 3 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in Mean SFI During Week 4 of Treatment | Baseline, Week 4 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | percentage of immobile bouts | MEAN |
| PRIMARY | Core Phase: Change From Baseline in the Mean Duration of Wake Bouts (aMeanDurWB) During Week 1 of Treatment | Baseline, Week 1 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | minutes | MEAN |
| PRIMARY | Core Phase: Change From Baseline in the aMeanDurWB During Week 2 of Treatment | Baseline, Week 2 | The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment. | minutes | MEAN |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 outcomesResults by group574
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Core Phase: Lemborexant-matched Placebo | Baseline | 76.34 | Standard Deviation 6.559 | percentage of sleep time |
| Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Core Phase: Lemborexant 2.5 mg | Baseline | 77.64 | Standard Deviation 7.883 | percentage of sleep time |
| Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Core Phase: Lemborexant 5 mg | Baseline | 78.45 | Standard Deviation 6.844 | percentage of sleep time |
| Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Core Phase: Lemborexant 10 mg | Baseline | 76.38 | Standard Deviation 8.037 | percentage of sleep time |
| Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Core Phase: Lemborexant 15 mg | Baseline | 77.35 | Standard Deviation 8.624 | percentage of sleep time |
| Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Core Phase: Lemborexant-matched Placebo | Change at Week 1 | 0.14 | Standard Deviation 5.766 | percentage of sleep time |
| Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Core Phase: Lemborexant 2.5 mg | Change at Week 1 | 2.43 | Standard Deviation 3.910 | percentage of sleep time |
| Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Core Phase: Lemborexant 5 mg | Change at Week 1 | 3.87 | Standard Deviation 4.646 | percentage of sleep time |
| Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Core Phase: Lemborexant 10 mg | Change at Week 1 | -0.17 | Standard Deviation 5.861 | percentage of sleep time |
| Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment | Core Phase: Lemborexant 15 mg | Change at Week 1 | 0.05 | Standard Deviation 4.475 | percentage of sleep time |
1 to 10 of 574Source ClinicalTrials.gov
See all 574 results by groupParticipant flow56
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Phase | STARTED | Core Phase: Lemborexant-matched Placebo | 12 | |
| Core Phase | STARTED | Core Phase: Lemborexant 2.5 mg | 12 | |
| Core Phase | STARTED | Core Phase: Lemborexant 5 mg | 14 | |
| Core Phase | STARTED | Core Phase: Lemborexant 10 mg | 13 | |
| Core Phase | STARTED | Core Phase: Lemborexant 15 mg | 12 | |
| Core Phase | STARTED | Extension Phase: Lemborexant 5 mg | 0 | |
| Core Phase | STARTED | Extension Phase: Lemborexant 10 mg | 0 | |
| Core Phase | STARTED | Extension Phase: Lemborexant 15 mg | 0 | |
| Core Phase | Treated | Core Phase: Lemborexant-matched Placebo | 12 | |
| Core Phase | Treated | Core Phase: Lemborexant 2.5 mg | 12 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 participant flowAdverse events424
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 | Atrioventricular block first degree | Cardiac disorders | Core Phase: Lemborexant-matched Placebo | 0 | 12 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Core Phase: Lemborexant 2.5 mg | 0 | 12 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Core Phase: Lemborexant 5 mg | 1 | 13 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | Core Phase: Lemborexant 10 mg | 0 | 13 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Core Phase: Lemborexant 15 mg | 0 | 12 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Extension Phase: Lemborexant 5 mg | 0 | 5 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Extension Phase: Lemborexant 10 mg | 1 | 14 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | Extension Phase: Lemborexant 15 mg | 0 | 6 | 0 |
| other | Bradycardia | Cardiac disorders | Core Phase: Lemborexant-matched Placebo | 0 | 12 | 0 |
| other | Bradycardia | Cardiac disorders | Core Phase: Lemborexant 2.5 mg | 0 | 12 | 0 |
1 to 10 of 424Source ClinicalTrials.gov
See all 424 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Core Phase: Lemborexant-matched Placebo | 0 | 12 |
| Total, all-cause mortality | Core Phase: Lemborexant 2.5 mg | 0 | 12 |
| Total, all-cause mortality | Core Phase: Lemborexant 5 mg | 0 | 13 |
| Total, all-cause mortality | Core Phase: Lemborexant 10 mg | 0 | 13 |
| Total, all-cause mortality | Core Phase: Lemborexant 15 mg | 0 | 12 |
| Total, all-cause mortality | Extension Phase: Lemborexant 5 mg | 0 | 5 |
| Total, all-cause mortality | Extension Phase: Lemborexant 10 mg | 0 | 14 |
| Total, all-cause mortality | Extension Phase: Lemborexant 15 mg | 0 | 6 |
| Total, other adverse events | Core Phase: Lemborexant-matched Placebo | 4 | 12 |
| Total, other adverse events | Core Phase: Lemborexant 2.5 mg | 3 | 12 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03001557
GET https://conductscience.org/api/trials/v1/NCT03001557/registered?page=2