Trial · NCT01995838
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
NCT01995838, Phase 2, Completed, Eisai Inc.; results first posted 2020-01-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia. Trials, record NCT01995838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01995838
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
- NCT number
- NCT01995838
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 291 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Chronic Insomnia, Adults, Elderly
- Interventions
- E2006, Placebo
- First posted
- 2013-11-27
- Last updated
- 2020-01-31
- Results first posted
- 2020-01-31
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis | Baseline up to Day 3 | The utility of a dose was a function of both Sleep Efficiency (SE) and Karolinska Sleepiness Scale (KSS), constructed by specifying the 1-dimensional component for each outcome measure and then combining them multiplicatively. Sufficient utility was defined as a probability of having utility function \>1. Probability of having utility function \>1 at the end of study visit (full analysis) was reported. |
| Primary | Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment | 1 hour after morning wake time at Baseline and Days 15-16 | The KSS was used to measure next-day residual effects at prespecified time points. The KSS was a 9-point scale on which the participant rated their sleepiness from 1 (extremely alert) to 9 (extremely sleepy/fighting sleep), where higher scores indicated an increase in sleepiness. The end of treatment score was calculated by the mean scores at the timepoint at 1 hour after morning wake time of Day 15 and 16. |
| Secondary | Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 1-2 and Days 14-15 | Baseline, Days 1-2, and Days 14-15 | Sleep efficiency was calculated as total sleep time divided by time spent in bed multiplied by 100. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline. |
| Secondary | Mean Change From Baseline in Latency to Persistent Sleep (LPS) After Dosing on Days 1-2 and Days 14-15 | Baseline, Days 1-2, and Days 14-15 | LPS was calculated as minutes from lights off to the first 30-second epoch of 20 consecutive epochs of non-wakefulness. A decrease in LPS indicated improvement in time needed to fall asleep. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline. |
| Secondary | Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) After Dosing on Days 1-2 and Days 14-15 | Baseline, Days 1-2, and Days 14-15 | WASO was calculated as minutes of wakefulness from the onset of persistent sleep until lights on. A decrease in WASO indicated improvement in sleep maintenance. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline. |
| Secondary | Potential Habituation Effect: Comparison Between Mean Change From Baseline in SE on Days 1-2 and Mean Change From Baseline in SE on Days 14-15 | Baseline, Days 1-2, and Days 14-15 | Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean SE of Days 14-15 minus change from baseline of mean SE of Days 1-2. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep. |
| Secondary | Potential Habituation Effect: Comparison Between Mean Change From Baseline in Latency to Persistent Sleep (LPS) on Days 1-2 and Mean Change From Baseline in LPS on Days 14-15 | Baseline and Days 1-2, and Days 14-15 | Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean LPS of Days 14-15 minus change from baseline of mean LPS of Days 1-2. LPS was calculated as minutes from lights off to the first 30-second epoch of 20 consecutive epochs of non-wakefulness. A decrease in LPS indicated improvement in time needed to fall asleep. |
| Secondary | Potential Habituation Effect: Comparison Between Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) on Days 1-2 and Mean Change From Baseline in WASO on Days 14-15 | Baseline, Days 1-2, and Days 14-15 | Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean WASO of Days 14-15 minus change from baseline of mean WASO of Days 1-2. WASO was calculated as minutes of wakefulness from the onset of persistent sleep until lights on. A decrease in WASO indicated improvement in sleep maintenance. |
| Secondary | Rebound Insomnia: Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 16-17 | Baseline and Days 16-17 | Rebound insomnia was assessed by comparing the change from baseline of the mean SE on Days 16-17. Sleep efficiency was calculated as total sleep time divided by time spent in bed multiplied by 100. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep. A negative change from baseline in SE indicated that SE was worse on Days 16 and 17 than at Baseline, which was considered as evidence for rebound insomnia. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAEs: Baseline up to Day 30, SAEs: Baseline up to 30 days after last dose of study drug (up to 47 days) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis | Baseline up to Day 3 | The full analysis set (FAS) included all participants who were randomized, received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. | probability | NUMBER |
| PRIMARY | Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment | 1 hour after morning wake time at Baseline and Days 15-16 | The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, number of participants analyzed (N) represents participants who were available for analysis at the specified timepoints. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 1-2 and Days 14-15 | Baseline, Days 1-2, and Days 14-15 | The FAS included all participants who were randomized, received at least 1 dose of study drug, had at least 1 post-dose primary efficacy measurement with both baseline and post baseline data available for analysis at each timepoints. | percentage of sleep time | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Latency to Persistent Sleep (LPS) After Dosing on Days 1-2 and Days 14-15 | Baseline, Days 1-2, and Days 14-15 | The FAS included all participants who were randomized, received at least 1 dose of study drug, had at least 1 post-dose primary efficacy measurement with both baseline and post baseline data available for analysis at each timepoints. | minutes | MEAN |
| SECONDARY | Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) After Dosing on Days 1-2 and Days 14-15 | Baseline, Days 1-2, and Days 14-15 | The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, number of participants analyzed (N) represents participants who were available for analysis at the specified timepoints. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Potential Habituation Effect: Comparison Between Mean Change From Baseline in SE on Days 1-2 and Mean Change From Baseline in SE on Days 14-15 | Baseline, Days 1-2, and Days 14-15 | The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percentage of sleep time | MEAN |
| SECONDARY | Potential Habituation Effect: Comparison Between Mean Change From Baseline in Latency to Persistent Sleep (LPS) on Days 1-2 and Mean Change From Baseline in LPS on Days 14-15 | Baseline and Days 1-2, and Days 14-15 | The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | minutes | MEAN |
| SECONDARY | Potential Habituation Effect: Comparison Between Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) on Days 1-2 and Mean Change From Baseline in WASO on Days 14-15 | Baseline, Days 1-2, and Days 14-15 | The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | minutes | MEAN |
| SECONDARY | Rebound Insomnia: Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 16-17 | Baseline and Days 16-17 | The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, number of participants analyzed (N) represents participants who were available for analysis at the specified timepoint. | percentage of sleep time | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAEs: Baseline up to Day 30, SAEs: Baseline up to 30 days after last dose of study drug (up to 47 days) | The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group118
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis | Lemborexant 1 mg | 0.8789 | probability | ||
| Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis | Lemborexant 2.5 mg | 0.8920 | probability | ||
| Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis | Lemborexant 5 mg | 0.9032 | probability | ||
| Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis | Lemborexant 10 mg | 0.9406 | probability | ||
| Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis | Lemborexant 15 mg | 0.9866 | probability | ||
| Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis | Lemborexant 25 mg | 0.9675 | probability | ||
| Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment | Lemborexant 1 mg | 0.29 | Standard Error 0.219 | Units on a scale | |
| Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment | Lemborexant 2.5 mg | -0.10 | Standard Error 0.234 | Units on a scale | |
| Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment | Lemborexant 5 mg | 0.20 | Standard Error 0.200 | Units on a scale | |
| Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment | Lemborexant 10 mg | -0.22 | Standard Error 0.219 | Units on a scale |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 56 | |
| Overall Study | STARTED | Lemborexant 1 Milligram (mg) | 32 | |
| Overall Study | STARTED | Lemborexant 2.5 mg | 27 | |
| Overall Study | STARTED | Lemborexant 5 mg | 38 | |
| Overall Study | STARTED | Lemborexant 10 mg | 32 | |
| Overall Study | STARTED | Lemborexant 15 mg | 56 | |
| Overall Study | STARTED | Lemborexant 25 mg | 50 | |
| Overall Study | COMPLETED | Placebo | 51 | |
| Overall Study | COMPLETED | Lemborexant 1 Milligram (mg) | 30 | |
| Overall Study | COMPLETED | Lemborexant 2.5 mg | 27 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events728
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 | Somnolence | Nervous system disorders | Lemborexant 1 mg | 1 | 32 | |
| other | Somnolence | Nervous system disorders | Lemborexant 2.5 mg | 1 | 27 | |
| other | Somnolence | Nervous system disorders | Lemborexant 5 mg | 2 | 38 | |
| other | Somnolence | Nervous system disorders | Lemborexant 10 mg | 4 | 32 | |
| other | Somnolence | Nervous system disorders | Lemborexant 15 mg | 10 | 56 | |
| other | Somnolence | Nervous system disorders | Lemborexant 25 mg | 11 | 50 | |
| other | Somnolence | Nervous system disorders | Placebo | 0 | 56 | |
| other | Headache | Nervous system disorders | Lemborexant 1 mg | 3 | 32 | |
| other | Headache | Nervous system disorders | Lemborexant 2.5 mg | 3 | 27 | |
| other | Headache | Nervous system disorders | Lemborexant 5 mg | 3 | 38 |
1 to 10 of 728Source ClinicalTrials.gov
See all 728 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lemborexant 1 mg | 0 | 32 |
| Total, all-cause mortality | Lemborexant 2.5 mg | 0 | 27 |
| Total, all-cause mortality | Lemborexant 5 mg | 0 | 38 |
| Total, all-cause mortality | Lemborexant 10 mg | 0 | 32 |
| Total, all-cause mortality | Lemborexant 15 mg | 0 | 56 |
| Total, all-cause mortality | Lemborexant 25 mg | 0 | 50 |
| Total, all-cause mortality | Placebo | 0 | 56 |
| Total, other adverse events | Lemborexant 1 mg | 11 | 32 |
| Total, other adverse events | Lemborexant 2.5 mg | 11 | 27 |
| Total, other adverse events | Lemborexant 5 mg | 16 | 38 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29065953 | 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.
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GET https://conductscience.org/api/trials/v1/NCT01995838/results?page=2