Trial · NCT02350309
Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
NCT02350309, Phase 1, Completed, Eisai Inc.; results first posted 2020-01-18
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ConductScience Library. Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder. Trials, record NCT02350309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02350309
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
- NCT number
- NCT02350309
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 69 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Insomnia Disorder
- Interventions
- Lemborexant 5 mg, Lemborexant 10 mg, Lemborexant-matched placebo., Flurazepam 30 mg
- First posted
- 2015-01-29
- Last updated
- 2020-01-18
- Results first posted
- 2020-01-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3 | Baseline, Day 2 of each of three treatment periods that were separated by approximately 2 weeks (for a total of up to 4 weeks) | SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The multiple sleep latency test (MSLT) is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four Sleep Latency Tests (SLTs), with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes. The four SLTs for each participant were averaged to obtain the mean SOL. |
| Secondary | Number of Participants With an Average SOL of Less Than (<) 8.0 Minutes for Each Treatment | Day 2 of each of three treatment periods that were separated by approximately 2 weeks (for a total of up to 6 weeks) | SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes. The four SLTs for each participant were averaged to obtain the mean SOL. |
| Secondary | Number of Participants Whose Treatment Difference (Under Either Dose of Lemborexant) Average SOL Score is More Than (>) 6.0 Minutes Shorter Than Placebo | Day 2 of each of three treatment periods that are separated by approximately 2 weeks (for a total of up to 6 weeks) | SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes. The four SLTs for each participant were averaged to obtain the mean SOL. |
| Secondary | Number of Participants Whose Average SOL is <8.0 Minutes and >6.0 Minutes Shorter Than Placebo | Day 2 of each of three treatment periods that are separated by approximately 2 weeks (for a total of up to 6 weeks) | SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes. The four SLTs for each participant were averaged to obtain the mean SOL. |
| Secondary | Mean Change From Baseline in the Average SOL From the M-MSLT in Treatment Period 4 | Baseline, Day 2 of Treatment Period 4 (Week 6) | SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes. The four SLTs for each participant were averaged to obtain the mean SOL. |
| Secondary | Mean Plasma Concentrations of Lemborexant and Metabolite M10 in the Morning Following M-MSLT | Days 2, 16 and 30 within 20 minutes after the end of 4th SLT (up to 155 minutes after wake time) | The MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) That Led to Death and Study Drug Discontinuation | From first dose of study drug up to Day 54 | |
| Secondary | Number of Participants With Clinically Significant Abnormal Laboratory Values | From first dose of study drug up to Day 54 | |
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values | From first dose of study drug up to Day 54 | |
| Secondary | Number of Participants With Clinically Significant Shifts From Baseline in Electrocardiogram (ECG) Parameters | From first dose of study drug up to Day 54 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3 | Baseline, Day 2 of each of three treatment periods that were separated by approximately 2 weeks (for a total of up to 4 weeks) | The full analysis set (FAS) was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose pharmacodynamics (PD) measurement. | minutes | MEAN |
| SECONDARY | Number of Participants With an Average SOL of Less Than (<) 8.0 Minutes for Each Treatment | Day 2 of each of three treatment periods that were separated by approximately 2 weeks (for a total of up to 6 weeks) | The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose PD measurement. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Whose Treatment Difference (Under Either Dose of Lemborexant) Average SOL Score is More Than (>) 6.0 Minutes Shorter Than Placebo | Day 2 of each of three treatment periods that are separated by approximately 2 weeks (for a total of up to 6 weeks) | The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose PD measurement. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Whose Average SOL is <8.0 Minutes and >6.0 Minutes Shorter Than Placebo | Day 2 of each of three treatment periods that are separated by approximately 2 weeks (for a total of up to 6 weeks) | The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose PD measurement. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in the Average SOL From the M-MSLT in Treatment Period 4 | Baseline, Day 2 of Treatment Period 4 (Week 6) | The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose PD measurement. | minutes | MEAN |
| SECONDARY | Mean Plasma Concentrations of Lemborexant and Metabolite M10 in the Morning Following M-MSLT | Days 2, 16 and 30 within 20 minutes after the end of 4th SLT (up to 155 minutes after wake time) | The pharmacokinetic (PK) analysis set was the group of participants who received at least one dose of lemborexant and had at least one quantifiable postdose drug concentration. The PK analysis set where data at specified time points was available. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) That Led to Death and Study Drug Discontinuation | From first dose of study drug up to Day 54 | The safety analysis set was the group of participants who received at least one dose of study drug and had at least 1 postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormal Laboratory Values | From first dose of study drug up to Day 54 | The safety analysis set was the group of participants who received at least one dose of study drug and had at least 1 postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values | From first dose of study drug up to Day 54 | The safety analysis set was the group of participants who received at least one dose of study drug and had at least 1 postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Shifts From Baseline in Electrocardiogram (ECG) Parameters | From first dose of study drug up to Day 54 | The safety analysis set was the group of participants who received at least one dose of study drug and had at least 1 postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group59
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3 | Lemborexant-matched Placebo | Baseline | 18.25 | Standard Deviation 2.621 | minutes |
| Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3 | Lemborexant 5 mg | Baseline | 18.28 | Standard Deviation 2.61 | minutes |
| Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3 | Lemborexant 10 mg | Baseline | 18.25 | Standard Deviation 2.621 | minutes |
| Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3 | Lemborexant-matched Placebo | Change at Day 2 After Each Treatment | -3.43 | Standard Deviation 4.424 | minutes |
| Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3 | Lemborexant 5 mg | Change at Day 2 After Each Treatment | -4.56 | Standard Deviation 4.693 | minutes |
| Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3 | Lemborexant 10 mg | Change at Day 2 After Each Treatment | -6.95 | Standard Deviation 4.967 | minutes |
| Number of Participants With an Average SOL of Less Than (<) 8.0 Minutes for Each Treatment | Lemborexant-matched Placebo | 3 | Participants | ||
| Number of Participants With an Average SOL of Less Than (<) 8.0 Minutes for Each Treatment | Lemborexant 5 mg | 11 | Participants | ||
| Number of Participants With an Average SOL of Less Than (<) 8.0 Minutes for Each Treatment | Lemborexant 10 mg | 20 | Participants | ||
| Number of Participants With an Average SOL of Less Than (<) 8.0 Minutes for Each Treatment | Flurazepam 30 mg | 36 | Participants |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 results by groupParticipant flow126
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (2 Days) | STARTED | Placebo, Lemborexant 5 mg, Lemborexant 10 mg, Flurazepam 30 mg | 12 | |
| Treatment Period 1 (2 Days) | STARTED | Lemborexant 10 mg, Placebo, Lemborexant 5 mg, Flurazepam 30 mg | 11 | |
| Treatment Period 1 (2 Days) | STARTED | Lemborexant 5 mg, Lemborexant 10 mg, Placebo, Flurazepam 30 mg | 11 | |
| Treatment Period 1 (2 Days) | STARTED | Lemborexant 10 mg, Lemborexant 5 mg, Placebo, Flurazepam 30 mg | 11 | |
| Treatment Period 1 (2 Days) | STARTED | Lemborexant 5 mg, Placebo, Lemborexant 10 mg, Flurazepam 30 mg | 12 | |
| Treatment Period 1 (2 Days) | STARTED | Placebo, Lemborexant 10 mg, Lemborexant 5 mg, Flurazepam 30 mg | 12 | |
| Treatment Period 1 (2 Days) | COMPLETED | Placebo, Lemborexant 5 mg, Lemborexant 10 mg, Flurazepam 30 mg | 12 | |
| Treatment Period 1 (2 Days) | COMPLETED | Lemborexant 10 mg, Placebo, Lemborexant 5 mg, Flurazepam 30 mg | 11 | |
| Treatment Period 1 (2 Days) | COMPLETED | Lemborexant 5 mg, Lemborexant 10 mg, Placebo, Flurazepam 30 mg | 10 | |
| Treatment Period 1 (2 Days) | COMPLETED | Lemborexant 10 mg, Lemborexant 5 mg, Placebo, Flurazepam 30 mg | 11 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 participant flowAdverse events44
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 | Diarrhoea | Gastrointestinal disorders | Lemborexant-matched Placebo | 0 | 68 | |
| other | Diarrhoea | Gastrointestinal disorders | Lemborexant 5 mg | 1 | 69 | |
| other | Diarrhoea | Gastrointestinal disorders | Lemborexant 10 mg | 0 | 68 | |
| other | Diarrhoea | Gastrointestinal disorders | Flurazepam 30 mg | 0 | 68 | |
| other | Dry mouth | Gastrointestinal disorders | Lemborexant-matched Placebo | 0 | 68 | |
| other | Dry mouth | Gastrointestinal disorders | Lemborexant 5 mg | 0 | 69 | |
| other | Dry mouth | Gastrointestinal disorders | Lemborexant 10 mg | 1 | 68 | |
| other | Dry mouth | Gastrointestinal disorders | Flurazepam 30 mg | 0 | 68 | |
| other | Dyspepsia | Gastrointestinal disorders | Lemborexant-matched Placebo | 0 | 68 | |
| other | Dyspepsia | Gastrointestinal disorders | Lemborexant 5 mg | 0 | 69 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lemborexant-matched Placebo | 0 | 68 |
| Total, all-cause mortality | Lemborexant 5 mg | 0 | 69 |
| Total, all-cause mortality | Lemborexant 10 mg | 0 | 68 |
| Total, all-cause mortality | Flurazepam 30 mg | 0 | 68 |
| Total, other adverse events | Lemborexant-matched Placebo | 2 | 68 |
| Total, other adverse events | Lemborexant 5 mg | 5 | 69 |
| Total, other adverse events | Lemborexant 10 mg | 8 | 68 |
| Total, other adverse events | Flurazepam 30 mg | 5 | 68 |
| Total, serious adverse events | Lemborexant-matched Placebo | 0 | 68 |
| Total, serious adverse events | Lemborexant 5 mg | 0 | 69 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37193566 | 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.
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