Healthy ParticipantsPhase 1NCT02583451
Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects
A Phase 1 study testing Zopiclone 7.5 mg, Lemborexant 2.5 mg and Lemborexant 5 mg in people with Healthy Participants, run by Eisai Inc. at 1 site in Netherlands.
Trial summary
This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Zopiclone 7.5 mg, Lemborexant 2.5 mg and Lemborexant 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2015to Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, male or female, aged 21 years or older at Screening
- Regular time spent in bed between 7.0 and 8.5 hours per night
- Regular bedtime, defined as the time the participant attempts to fall asleep, between 22:00 hours and 01:00 hours, and regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 hours and 09:00 hours
- Body mass index (BMI) ≥18 and <31 kg/m2 at Screening
- Subjective sleep onset latency (sSOL) <30 minutes and subjective wake after sleep onset (sWASO) <60 minutes on the Sleep Diary
- At least 3 years of experience driving at least 3000 km per year
Show all 9Show fewer
- Holds a valid license to drive a vehicle in the European Union (EU) as confirmed at the Screening visit
- Has driving ability during the practice driving test that is judged to be adequate by the driving instructor
- Able to communicate adequately (written and verbal) in either Dutch or English as determined by the investigator
Who cannot join
- A current complaint or diagnosis of insomnia disorder (per either The Diagnostic and Statistical Manual of Mental Disorders Version IV [DSM-IV] or Version 5 [DSM-5] criteria), sleep-related breathing disorder, periodic limb movement disorder, restless legs or narcolepsy, or an exclusionary score on a subscale of the SLEEP50
- Habitually naps more than 3 times per week
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- Females of childbearing potential who:
- Had unprotected sexual intercourse within 30 days before study entry and who 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 sexually active during the study period or for 28 days after study drug discontinuation.
Show all 25Show fewer
- 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 who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation. (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]).
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation.
- Clinically significant illness that requires medical treatment between Screening and Baseline
- Any clinically abnormal symptom or organ impairment found by medical history at Screening or Baseline and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment
- Has a QT interval corrected using Fridericia's formula interval (QTcF interval) >450 ms demonstrated on repeated ECGs (repeated only if initial ECG showed corrected QT interval (QTc) >450 ms) at Screening or Baseline
- Has a history of or a family history of congenital QT prolongation or with a history of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome), or uses concomitant medications that prolong the QT/QT interval corrected for heart rate (QTc interval)
- Has systolic blood pressure (BP) >140 mmHg (age 21-59) or >150 mmHg (age ≥60) or diastolic BP >90 mmHg (all ages) at Screening or Baseline
- Has a resting heart rate <50 or ≥100 beats/min at Screening or Baseline
- Has a history of drug or alcohol dependency or abuse (as defined by DSM-5 criteria) within approximately 2 years before Screening
- Any suicidal ideation with intent with or without a plan within 6 months of the Screening Period (ie, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS)
- Habitually consumes more than 14 drinks per week (females) or more than 21 drinks per week (males)
- Has a positive alcohol breathalyzer test at Screening or Baseline check-in
- Smokes more than 6 cigarettes per day habitually and is unwilling to abstain from smoking cigarettes on evenings spent in the clinic until discharge after the driving test
- Habitually consumes more than 3 cups of caffeinated beverages per day
- Used any prohibited prescription or over-the-counter (OTC) concomitant medications within 1 week prior to starting the Sleep Diary during the Screening Period
- Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline or plans for transmeridian travel across more than 3 time zones during the study
- A positive urine drug test at Screening or unwilling to refrain from use of illegal recreational drugs or marijuana during the study
- Hypersensitivity to the study drug or any of the excipients or to zopiclone
- Participated (received investigational product) in another clinical trial less than 1 month (or 5 elimination half-lives of the investigational product) before dosing or is currently enrolled in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, 4-Period Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects
This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance
Read the detailed description
The study will have 2 phases, Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods that will last up to a maximum of 21 days: Screening and Baseline. The Randomization Phase will comprise of four, 9-day treatment periods (Treatment Period 1 - Treatment Period 4) with a minimum 14-day washout between treatment periods, and a follow-up interval of at least 14 days after Treatment Period 4 before the end-of-study (EOS) visit. Participants will be randomized to 1 of 12 sequences in an incomplete blocks design.
- Conditions
- Healthy Participants
- Being tested
- Placebo tablet matching lemborexant, Placebo tablet matching zopiclone, Zopiclone 7.5 mg, Lemborexant 2.5 mg, Lemborexant 5 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo tablet matching lemborexantDrug
Tablet form taken orally at bedtime.
Placebo tablet matching zopicloneDrug
Tablet form taken orally at bedtime.
Zopiclone 7.5 mgDrug
7.5 mg tablet taken orally at bedtime.
Lemborexant 2.5 mgDrug
2.5 tablet taken orally at bedtime.
Lemborexant 5 mgDrug
5 mg tablet taken orally at bedtime.
Lemborexant 10 mgDrug
10 mg tablet taken orally at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Treatment A is a placebo tablet matching lemborexant and placebo tablet matching zopiclone on nights in the clinic; placebo tablet matching lemborexant on nights at home. Receives: Drug: Placebo tablet matching lemborexant; Drug: Placebo tablet matching zopiclone |
| Treatment B | Experimental | Treatment B is zopiclone 7.5 mg tablet and placebo tablet matching lemborexant on nights in the clinic; placebo tablet matching lemborexant on nights at home. Receives: Drug: Placebo tablet matching lemborexant; Drug: Zopiclone 7.5 mg |
| Treatment C | Experimental | Treatment C is lemborexant 2.5 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 2.5 mg tablet on nights at home. Receives: Drug: Placebo tablet matching zopiclone; Drug: Lemborexant 2.5 mg |
| Treatment D | Experimental | Treatment D is lemborexant 5 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 5 mg tablet on nights at home. Receives: Drug: Placebo tablet matching zopiclone; Drug: Lemborexant 5 mg |
| Treatment E | Experimental | Treatment E is lemborexant 10 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 10 mg tablet on nights at home. Receives: Drug: Placebo tablet matching zopiclone; Drug: Lemborexant 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of standard deviation of lateral position (SDLP) during an on-road driving test
Measured: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Secondary outcomes (8)
Number of lapses on the driving test
Measured: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Outliers on SDLP
Measured: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Outliers on number of lapses
Measured: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Percentage of participants who never started a scheduled driving test or who stopped prematurely
Measured: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Standard deviation of lateral position (SDLP) during an on-road driving test, by age group
Measured: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Plasma concentration of lemborexant
Measured: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Number of lapses on the driving test, by age group
Measured: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Plasma concentration of S-zopiclone
Measured: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion31 Jan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583451
- Sponsor's protocol ID
- E2006-E044-106
- Status last verified
- Nov 2017
- First submitted
- 16 Oct 2015
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gotfried MH, Auerbach SH, Dang-Vu TT, Mishima K, Kumar D, Moline M, Malhotra M. Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials. Drugs Aging. 2024 Sep;41(9):741-752. doi: 10.1007/s40266-024-01135-8. Epub 2024 Aug 9.
PubMed 39120786Vermeeren A, Jongen S, Murphy P, Moline M, Filippov G, Pinner K, Perdomo C, Landry I, Majid O, Van Oers ACM, Van Leeuwen CJ, Ramaekers JG, Vuurman EFPM. On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers. Sleep. 2019 Apr 1;42(4):zsy260. doi: 10.1093/sleep/zsy260.
PubMed 30597112
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled, 4-Period Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT02583451
- Acronym / sponsor ID
- E2006-E044-106
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Study start
- Nov 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
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 randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance
Detailed description
The study will have 2 phases, Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods that will last up to a maximum of 21 days: Screening and Baseline. The Randomization Phase will comprise of four, 9-day treatment periods (Treatment Period 1 - Treatment Period 4) with a minimum 14-day washout between treatment periods, and a follow-up interval of at least 14 days after Treatment Period 4 before the end-of-study (EOS) visit. Participants will be randomized to 1 of 12 sequences in an incomplete blocks design.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Placebo tablet matching lemborexant, Drug: Placebo tablet matching zopicloneTreatment A is a placebo tablet matching lemborexant and placebo tablet matching zopiclone on nights in the clinic; placebo tablet matching lemborexant on nights at home. |
| Treatment B | Experimental | Drug: Placebo tablet matching lemborexant, Drug: Zopiclone 7.5 mgTreatment B is zopiclone 7.5 mg tablet and placebo tablet matching lemborexant on nights in the clinic; placebo tablet matching lemborexant on nights at home. |
| Treatment C | Experimental | Drug: Placebo tablet matching zopiclone, Drug: Lemborexant 2.5 mgTreatment C is lemborexant 2.5 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 2.5 mg tablet on nights at home. |
| Treatment D | Experimental | Drug: Placebo tablet matching zopiclone, Drug: Lemborexant 5 mgTreatment D is lemborexant 5 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 5 mg tablet on nights at home. |
| Treatment E | Experimental | Drug: Placebo tablet matching zopiclone, Drug: Lemborexant 10 mgTreatment E is lemborexant 10 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 10 mg tablet on nights at home. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy, male or female, aged 21 years or older at Screening
- Regular time spent in bed between 7.0 and 8.5 hours per night
- Regular bedtime, defined as the time the participant attempts to fall asleep, between 22:00 hours and 01:00 hours, and regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 hours and 09:00 hours
- Body mass index (BMI) ≥18 and <31 kg/m2 at Screening
- Subjective sleep onset latency (sSOL) <30 minutes and subjective wake after sleep onset (sWASO) <60 minutes on the Sleep Diary
Key exclusion criteria (25 listed)
- A current complaint or diagnosis of insomnia disorder (per either The Diagnostic and Statistical Manual of Mental Disorders Version IV [DSM-IV] or Version 5 [DSM-5] criteria), sleep-related breathing disorder, periodic limb movement disorder, restless legs or narcolepsy, or an exclusionary score on a subscale of the SLEEP50
- Habitually naps more than 3 times per week
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- Females of childbearing potential who:
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation.
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 |
|---|---|---|
| Placebo tablet matching lemborexantTablet form taken orally at bedtime. | Drug | Treatment A, Treatment B |
| Placebo tablet matching zopicloneTablet form taken orally at bedtime. | Drug | Treatment A, Treatment C, Treatment D, Treatment E |
| Zopiclone 7.5 mg7.5 mg tablet taken orally at bedtime. | Drug | Treatment B |
| Lemborexant 2.5 mg2.5 tablet taken orally at bedtime. | Drug | Treatment C |
| Lemborexant 5 mg5 mg tablet taken orally at bedtime. | Drug | Treatment D |
| Lemborexant 10 mg10 mg tablet taken orally at bedtime. | Drug | Treatment E |
Primary outcome
Change of standard deviation of lateral position (SDLP) during an on-road driving test
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
8 secondary outcomes
Number of lapses on the driving test
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Outliers on SDLP
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Outliers on number of lapses
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Percentage of participants who never started a scheduled driving test or who stopped prematurely
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Standard deviation of lateral position (SDLP) during an on-road driving test, by age group
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Plasma concentration of lemborexant
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Number of lapses on the driving test, by age group
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Plasma concentration of S-zopiclone
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Derived from this study: PubMed 39120786Gotfried MH, Auerbach SH, Dang-Vu TT, Mishima K, Kumar D, Moline M, Malhotra M. Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials. Drugs Aging. 2024 Sep;41(9):741-752. doi: 10.1007/s40266-024-01135-8. Epub 2024 Aug 9.
- Derived from this study: PubMed 30597112Vermeeren A, Jongen S, Murphy P, Moline M, Filippov G, Pinner K, Perdomo C, Landry I, Majid O, Van Oers ACM, Van Leeuwen CJ, Ramaekers JG, Vuurman EFPM. On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers. Sleep. 2019 Apr 1;42(4):zsy260. doi: 10.1093/sleep/zsy260.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zopiclone 7.5 mg, Lemborexant 2.5 mg and Lemborexant 5 mg in people with Healthy Participants, run by Eisai Inc. at 1 site in Netherlands.
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 9 inclusion and 25 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of standard deviation of lateral position (SDLP) during an on-road driving test (time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72). 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 NCT02583451, which also lists 2 linked publications.
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 6 Sep 2018.