Insomnia DisorderPhase 1NCT02350309
Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
A Phase 1 study testing Lemborexant 5 mg, Lemborexant 10 mg and Flurazepam 30 mg in people with Insomnia Disorder, run by Eisai Inc. at 2 sites in United States.
Trial summary
This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Lemborexant 5 mg, Lemborexant 10 mg and Flurazepam 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Dec 2014to 21 Apr 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 or older, at the time of informed consent.
- Meets the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia Disorder, as follows:
- Complains of dissatisfaction with nighttime sleep despite adequate opportunity for sleep, with complaint being one or more of the following: difficulty getting to sleep, difficulty staying asleep, or awakening earlier in the morning than desired.
- Frequency of complaint greater than or equal to 3 times per week.
- Duration of complaint greater than or equal to 3 months.
- Associated with complaint of daytime impairment.
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- Insomnia Severity Index score greater than or equal to 15 at Screening.
- Regular time in bed between 7 and 9 hours as reported at Screening.
- Regular bedtime, defined as the time the participant attempts to fall asleep, between 21:00 and 24:00 and regular wake time between 05:00 and 09:00 as reported at Screening.
- Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary completed for 7 nights during Screening, such that participant Sleep Onset Latency (sSOL) greater than or equal to 30 minutes on at least 3 nights and subjective Wake After Sleep Onset (sWASO) greater than or equal to 60 minutes on at least 3 nights.
Who cannot join
- Excessive morning sleepiness at Baseline as determined by average SOL at Baseline less than 10 minutes.
- Females must not be lactating or pregnant at Screening or Baseline (documented by a negative beta-human chorionic gonadotropin [beta-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG or hCG). (Note: A negative urine pregnancy test is required at check-in before each dose of study drug and flurazepam).
- If females of childbearing potential:
- Had unprotected sexual intercourse within 30 days before study entry and do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation.
- Are currently abstinent, and do not agree to use a double barrier method (as described above) or refrain from sexual activity during the study period or for 28 days after study drug discontinuation.
- Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
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- NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia.
- Reports experiencing within the past year confusional arousals, symptoms of REM Behavior Disorder, or sleep-related violent behavior on Munich Parasomnia Scale (MUPS), or a history of aberrant nocturnal behaviors including sleep-driving or sleep-eating.
- Habitually naps more than 3 times per week.
- History of drug or alcohol dependency or abuse within approximately the last 2 years.
- Has a positive drug screen at Screening.
- A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated ECG at Screening (repeated only if initial ECG indicates a QTc interval greater than 450 ms).
- Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening or any lifetime suicidal behavior.
- Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal, psychiatric or neurological disease, or chronic pain) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.
- Used any prohibited prescription or over-the-counter concomitant medications within 2 weeks prior to Screening, or between Screening and Randomization.
- Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 2 weeks prior to Screening, or between Screening and Randomization.
- Scheduled for surgery during the study.
- Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline, or plans to travel more than 3 times zones during the study.
- Hypersensitivity to flurazepam, the study drug, or any of the excipients.
- Currently enrolled in another clinical trial or used any investigational drug or device within 28 days or 5 x the half-life, whichever is longer preceding informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Atlanta, Georgia, 30342
Study site
Crestview Hills, Kentucky, 41017
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover Study to Evaluate the Effect of 2 Dosage Strengths of E2006 on a Multiple Sleep Latency Test in Subjects With Insomnia Disorder
This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.
Read the detailed description
The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods that taken together, will last up to a maximum of 21 days: a Screening Period and a Baseline Period. The Randomization Phase will comprise 4 treatment periods (Treatment 1, Treatment 2, Treatment 3, Treatment 4) with intervening washout periods between treatment periods (Washout 1, Washout 2, Washout 3). A single dose of study drug will be administered in a randomized, 3-way double-blind crossover manner at Treatment Periods 1-3; flurazepam 30 mg will be administered in an open-label manner at Treatment Period 4.
- Conditions
- Insomnia Disorder
- Being tested
- Lemborexant 5 mg, Lemborexant 10 mg, Lemborexant-matched placebo., Flurazepam 30 mg
- Keywords
- Insomnia Disorder, E2006, Multiple Sleep Latency Test, Lemborexant
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemborexant 5 mgDrug
Also called E2006
Lemborexant 5 mg tablet.
Lemborexant 10 mgDrug
Also called E2006
Lemborexant 10 mg tablet.
Lemborexant-matched placebo.Drug
Also called E2006
Lemborexant-matched placebo tablet.
Flurazepam 30 mgDrug
Flurazepam 30 mg capsule.
| Study group | Role | What they receive |
|---|---|---|
| Lemborexant 5 mg | Experimental | Participants will receive a single, oral tablet formulation dose of lemborexant 5 mg within 5 minutes before bedtime. Receives: Drug: Lemborexant 5 mg |
| Lemborexant 10 mg | Experimental | Participants will receive a single, oral tablet formulation dose of lemborexant 10 mg within 5 minutes before bedtime. Receives: Drug: Lemborexant 10 mg |
| Lemborexant-matched Placebo | Placebo comparator | Participants will receive a single, oral tablet formulation dose of lemborexant-matched placebo within 5 minutes before bedtime. Receives: Drug: Lemborexant-matched placebo. |
| Flurazepam 30 mg | Active comparator | Participants will receive a single, oral capsule formulation dose of flurazepam 30 mg within 5 minutes before bedtime. Receives: Drug: Flurazepam 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline, Day 2 of each of three treatment periods that were separated by approximately 2 weeks (for a total of up to 4 weeks)
Secondary outcomes (10)
Number of Participants With an Average SOL of Less Than (<) 8.0 Minutes for Each Treatment
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.
Measured: Day 2 of each of three treatment periods that were separated by approximately 2 weeks (for a total of up to 6 weeks)
Number of Participants Whose Treatment Difference (Under Either Dose of Lemborexant) Average SOL Score is More Than (>) 6.0 Minutes Shorter Than Placebo
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.
Measured: Day 2 of each of three treatment periods that are separated by approximately 2 weeks (for a total of up to 6 weeks)
Number of Participants Whose Average SOL is <8.0 Minutes and >6.0 Minutes Shorter Than Placebo
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.
Measured: Day 2 of each of three treatment periods that are separated by approximately 2 weeks (for a total of up to 6 weeks)
Mean Change From Baseline in the Average SOL From the M-MSLT in Treatment Period 4
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.
Measured: Baseline, Day 2 of Treatment Period 4 (Week 6)
Mean Plasma Concentrations of Lemborexant and Metabolite M10 in the Morning Following M-MSLT
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.
Measured: Days 2, 16 and 30 within 20 minutes after the end of 4th SLT (up to 155 minutes after wake time)
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
Measured: From first dose of study drug up to Day 54
Number of Participants With Clinically Significant Abnormal Laboratory Values
Measured: From first dose of study drug up to Day 54
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
Measured: From first dose of study drug up to Day 54
Number of Participants With Clinically Significant Shifts From Baseline in Electrocardiogram (ECG) Parameters
Measured: From first dose of study drug up to Day 54
Relationship Between PK Concentrations of Lemborexant and Sleepiness as Measured by M-MSLT
Pearson correlation was used to calculate the relationship between PK concentration of lemborexant and sleepiness. The M-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.
Measured: Baseline up to Day 44 (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study start13 Dec 2014
- Primary completion21 Apr 2015
- Study completion21 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350309
- Sponsor's protocol ID
- E2006-A001-107
- Status last verified
- Dec 2016
- First submitted
- 7 Jan 2015
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Publications
Mayleben D, Rosenberg R, Pinner K, Hussein Z, Moline M. Assessment of morning sleep propensity with lemborexant in adults with insomnia disorder in a randomized, placebo-controlled crossover study. Sleep Adv. 2021 Jul 2;2(1):zpab011. doi: 10.1093/sleepadvances/zpab011. eCollection 2021.
PubMed 37193566
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover Study to Evaluate the Effect of 2 Dosage Strengths of E2006 on a Multiple Sleep Latency Test in Subjects With Insomnia Disorder
- ClinicalTrials.gov ID
- NCT02350309
- Acronym / sponsor ID
- E2006-A001-107
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia Disorder, E2006, Multiple Sleep Latency Test, Lemborexant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2014 (actual)
- Primary completion
- 21 Apr 2015 (actual)
- Study completion
- 21 Apr 2015 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.
Detailed description
The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods that taken together, will last up to a maximum of 21 days: a Screening Period and a Baseline Period. The Randomization Phase will comprise 4 treatment periods (Treatment 1, Treatment 2, Treatment 3, Treatment 4) with intervening washout periods between treatment periods (Washout 1, Washout 2, Washout 3). A single dose of study drug will be administered in a randomized, 3-way double-blind crossover manner at Treatment Periods 1-3; flurazepam 30 mg will be administered in an open-label manner at Treatment Period 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lemborexant 5 mg | Experimental | Drug: Lemborexant 5 mgParticipants will receive a single, oral tablet formulation dose of lemborexant 5 mg within 5 minutes before bedtime. |
| Lemborexant 10 mg | Experimental | Drug: Lemborexant 10 mgParticipants will receive a single, oral tablet formulation dose of lemborexant 10 mg within 5 minutes before bedtime. |
| Lemborexant-matched Placebo | Placebo comparator | Drug: Lemborexant-matched placebo.Participants will receive a single, oral tablet formulation dose of lemborexant-matched placebo within 5 minutes before bedtime. |
| Flurazepam 30 mg | Active comparator | Drug: Flurazepam 30 mgParticipants will receive a single, oral capsule formulation dose of flurazepam 30 mg within 5 minutes before bedtime. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, age 18 or older, at the time of informed consent.
- Meets the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia Disorder, as follows:
- Insomnia Severity Index score greater than or equal to 15 at Screening.
- Regular time in bed between 7 and 9 hours as reported at Screening.
- Regular bedtime, defined as the time the participant attempts to fall asleep, between 21:00 and 24:00 and regular wake time between 05:00 and 09:00 as reported at Screening.
Key exclusion criteria (21 listed)
- Excessive morning sleepiness at Baseline as determined by average SOL at Baseline less than 10 minutes.
- Females must not be lactating or pregnant at Screening or Baseline (documented by a negative beta-human chorionic gonadotropin [beta-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG or hCG). (Note: A negative urine pregnancy test is required at check-in before each dose of study drug and flurazepam).
- If females of childbearing potential:
- NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemborexant 5 mgAlso: E2006Lemborexant 5 mg tablet. | Drug | Lemborexant 5 mg |
| Lemborexant 10 mgAlso: E2006Lemborexant 10 mg tablet. | Drug | Lemborexant 10 mg |
| Lemborexant-matched placebo.Also: E2006Lemborexant-matched placebo tablet. | Drug | Lemborexant-matched Placebo |
| Flurazepam 30 mgFlurazepam 30 mg capsule. | Drug | Flurazepam 30 mg |
Primary outcome
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
Time frame: 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.
10 secondary outcomes
Number of Participants With an Average SOL of Less Than (<) 8.0 Minutes for Each Treatment
Time frame: Day 2 of each of three treatment periods that were separated by approximately 2 weeks (for a total of up to 6 weeks)
Number of Participants Whose Treatment Difference (Under Either Dose of Lemborexant) Average SOL Score is More Than (>) 6.0 Minutes Shorter Than Placebo
Time frame: Day 2 of each of three treatment periods that are separated by approximately 2 weeks (for a total of up to 6 weeks)
Number of Participants Whose Average SOL is <8.0 Minutes and >6.0 Minutes Shorter Than Placebo
Time frame: Day 2 of each of three treatment periods that are separated by approximately 2 weeks (for a total of up to 6 weeks)
Mean Change From Baseline in the Average SOL From the M-MSLT in Treatment Period 4
Time frame: Baseline, Day 2 of Treatment Period 4 (Week 6)
Mean Plasma Concentrations of Lemborexant and Metabolite M10 in the Morning Following M-MSLT
Time frame: Days 2, 16 and 30 within 20 minutes after the end of 4th SLT (up to 155 minutes after wake time)
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
Time frame: From first dose of study drug up to Day 54
Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: From first dose of study drug up to Day 54
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
Time frame: From first dose of study drug up to Day 54
Number of Participants With Clinically Significant Shifts From Baseline in Electrocardiogram (ECG) Parameters
Time frame: From first dose of study drug up to Day 54
Relationship Between PK Concentrations of Lemborexant and Sleepiness as Measured by M-MSLT
Time frame: Baseline up to Day 44 (Week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37193566Mayleben D, Rosenberg R, Pinner K, Hussein Z, Moline M. Assessment of morning sleep propensity with lemborexant in adults with insomnia disorder in a randomized, placebo-controlled crossover study. Sleep Adv. 2021 Jul 2;2(1):zpab011. doi: 10.1093/sleepadvances/zpab011. eCollection 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lemborexant 5 mg, Lemborexant 10 mg and Flurazepam 30 mg in people with Insomnia Disorder, run by Eisai Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, Day 2 of each of three treatment periods that were separated by approximately 2 weeks (for a total of up to 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02350309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.