Healthy SubjectsPhase 1NCT03008447
Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older
A Phase 1 study testing LEM5, LEM10 and ZOL in people with Healthy Subjects, run by Eisai Inc. at 4 sites in United States.
Trial summary
E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- LEM5, LEM10 and ZOL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Nov 2016to 3 Jan 2018
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking female participants, aged 55 years and older, or male participants, aged 65 years and older, at the time of informed consent
- Regular sleep timing and duration, per the following criteria:
- Regular time in bed, between 7 and 9 hours as reported at Screening and verified by the Sleep Diary during the Screening Period before the adaptation night such that time in bed is not less than 7 hours or more than 9 hours on more than 2 of the 7 consecutive nights recorded in the Sleep Diary
- Regular bedtime, defined as the time the participant attempts to fall asleep, between 22:00 and 01:00 and regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 and 09:00 as reported at Screening and verified by the Sleep Diary during the Screening Period before the adaptation night such that neither bedtime nor waketime is outside of the permitted time windows on more than 2 of the 7 consecutive nights
- Able to detect a 1000 Hertz (Hz) tone at 20 decibels (dB)
- Able to read English at an 8th-grade level
Who cannot join
- Is a female of childbearing potential Note: All females will be considered to be of childbearing potential unless they are postmenopausal (defined as amenorrheic for at least 12 consecutive months, and are postmenopausal without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- A current diagnosis of insomnia disorder, sleep-related breathing disorder, periodic limb movements disorder (PLMD), restless legs syndrome, circadian rhythm sleep disorder, narcolepsy, sleep-related violent behavior, sleep-driving, sleep-eating, or symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study
- Has subjective sleep onset latency (sSOL) > 20 minutes or subjective wake after sleep onset (sWASO) > 60 minutes on more than 2 nights as reported on the Sleep Diary during the Screening Period before the adaptation night
- Latency to persistent sleep (LPS) longer than 30 minutes as measured on the PSG on the Baseline night (or repeat Baseline night, if needed)
- Has a sleep onset Rapid eye movement (REM) period, defined as first epoch of stage REM within 15 minutes of sleep onset, as measured on the PSG on either the adaptation night or Baseline night (or repeat Baseline night, if needed)
- Apnea-Hypopnea Index > 15 or Periodic Limb Movement with Arousal Index > 15 as measured on the PSG on the adaptation night
Show all 26Show fewer
- Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
- History of fracture due to a fall within the past 5 years
- Evidence of orthostatic hypotension at Screening
- Use of hearing aid or clinically significant hearing loss
- Presence or history of Meniere's disease, labyrinthitis, benign paroxysmal positional vertigo, no recent vertigo from any other cause, no recent dizziness or head injury
- Unable to stand unaided for a minimum of 2 minutes
- At Screening, fails Romberg test in the clinical judgment of the investigator
- Significant vision loss or inability to read computer screen in <80 lumens per square meter (lux) ambient illumination
- History of drug or alcohol dependency or abuse within approximately the previous 2 years or have a positive urine drug screen at Screening or Baseline
- Self-reports consuming more than 14 alcohol-containing drinks per week (females) or 21 alcohol containing drinks per week (males) at Screening
- A prolonged QT/heart rate corrected QT interval (QTc) (QT interval corrected for Fridericia's formula [QTcF] > 450 milliseconds [ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening (repeated only if initial ECG indicates a QTcF interval > 450 ms)
- Any suicidal ideation at Screening or within 6 months of Screening or any lifetime suicidal behavior
- Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal, psychiatric or neurological disease, malignancy other than basal cell carcinoma, or chronic pain) or condition 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 1 week or 5 half lives, whichever is longer, before the Baseline night
- Scheduled for surgery during the study
- Transmeridian travel across more than 3 time zones in the 2 weeks before the first Baseline night, or plans to travel more than 3 time zones during the study.
- Currently enrolled in another clinical trial or used any investigational drug or device within 28 days or 5 half lives, whichever is longer preceding informed consent
- Hypersensitivity to lemborexant or zolpidem or any of their excipients
- Active viral hepatitis (B or C) as demonstrated by positive serology
- Previous exposure to lemborexant or suvorexant
Trial locations and contacts
4 sites in 1 country.
United States4 sites
NeuroTrials Research, Inc
Atlanta, Georgia, 30342
Community Research Management Associates d/b/a CTI Clinical Research Center
Cincinnati, Ohio, 45212
Clinilabs, Inc
New York, New York, 10019
Wake Research Assoicates, LLC
Raleigh, North Carolina, 27612
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled and Active Comparator, 4 Period Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older
E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose administration at bedtime.
- Conditions
- Healthy Subjects
- Being tested
- LEM5, LEM10, ZOL, PBO
- Keywords
- E2006, postural stability, auditory awakening threshold, cognitive performance, healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEM5Drug
Single dose of lemborexant 5 mg administered within 5 minutes before bedtime.
LEM10Drug
Single dose of lemborexant 10 mg administered within 5 minutes before bedtime.
ZOLDrug
Single dose of zolpidem 6.25 mg administered within 5 minutes before bedtime.
PBODrug
Single dose of placebo administered within 5 minutes before bedtime.
| Study group | Role | What they receive |
|---|---|---|
| LEM5; LEM10; PBO; ZOL | Experimental | Participants will receive LEM5 (one lemborexant [LEM] 5 milligram [mg] tablet and one zolpidem [ZOL]-matched placebo [PBO] tablet) in Treatment Period 1. In Treatment Period 2, participants will receive LEM10 (one LEM 10 mg tablet and one ZOL-matched PBO tablet). In Treatment Period 3, participants will receive PBO (one LEM-matched PBO tablet and one ZOL-matched PBO tablet). In Treatment Period 4, participants will receive ZOL (one LEM-matched PBO tablet and one ZOL 6.25 mg tablet). Receives: Drug: LEM5; Drug: LEM10; Drug: ZOL; Drug: PBO |
| LEM10; ZOL; LEM5; PBO | Experimental | Participants will receive LEM10, ZOL, LEM5, and PBO in Treatments Periods 1, 2, 3, and 4, respectively. Receives: Drug: LEM5; Drug: LEM10; Drug: ZOL; Drug: PBO |
| ZOL; PBO; LEM10; LEM5 | Experimental | Participants will receive ZOL, PBO, LEM10, and LEM5 in Treatment Periods 1, 2, 3, and 4, respectively. Receives: Drug: LEM5; Drug: LEM10; Drug: ZOL; Drug: PBO |
| PBO; LEM5; ZOL; LEM10 | Experimental | Participants will receive PBO, LEM5, ZOL, and LEM10 in Treatment Periods 1, 2, 3, and 4, respectively. Receives: Drug: LEM5; Drug: LEM10; Drug: ZOL; Drug: PBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to zolpidem (ZOL) at approximately 4 hours postdose
Magnitude of body sway upon being awakened at approximately 4 hours after receiving lemborexant 5 milligrams (mg) (LEM5), lemborexant 10 mg (LEM10), zolpidem 6.25 mg, or placebo.
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Secondary outcomes (12)
Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to ZOL and placebo (PBO) at approximately 8 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to PBO at approximately 4 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline in auditory awakening threshold (AAT) for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from power of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from power of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from continuity of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from continuity of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from quality of memory for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from quality of memory for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from speed of memory retrieval for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from speed of memory retrieval for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Measured: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Number of participants with any serious adverse event and number of participants with any non-serious adverse event
Measured: up to 72 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start21 Nov 2016
- Primary completion3 Jan 2018
- Study completion3 Jan 2018
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 SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT03008447
- Sponsor's protocol ID
- E2006-A001-108
- Status last verified
- Nov 2017
- First submitted
- 29 Dec 2016
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
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 39120786Murphy P, Kumar D, Zammit G, Rosenberg R, Moline M. Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakening. J Clin Sleep Med. 2020 May 15;16(5):765-773. doi: 10.5664/jcsm.8294. Epub 2020 Feb 6.
PubMed 32022664
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled and Active Comparator, 4 Period Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older
- ClinicalTrials.gov ID
- NCT03008447
- Acronym / sponsor ID
- E2006-A001-108
- Conditions
- Healthy Subjects
- Keywords
- E2006, postural stability, auditory awakening threshold, cognitive performance, healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 3 Jan 2018 (actual)
- First posted
- 2 Jan 2017 (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.
E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose administration at bedtime.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LEM5; LEM10; PBO; ZOL | Experimental | Drug: LEM5, Drug: LEM10, Drug: ZOL, Drug: PBOParticipants will receive LEM5 (one lemborexant [LEM] 5 milligram [mg] tablet and one zolpidem [ZOL]-matched placebo [PBO] tablet) in Treatment Period 1. In Treatment Period 2, participants will receive LEM10 (one LEM 10 mg tablet and one ZOL-matched PBO tablet). In Treatment Period 3, participants will receive PBO (one LEM-matched PBO tablet and one ZOL-matched PBO tablet). In Treatment Period 4, participants will receive ZOL (one LEM-matched PBO tablet and one ZOL 6.25 mg tablet). |
| LEM10; ZOL; LEM5; PBO | Experimental | Drug: LEM5, Drug: LEM10, Drug: ZOL, Drug: PBOParticipants will receive LEM10, ZOL, LEM5, and PBO in Treatments Periods 1, 2, 3, and 4, respectively. |
| ZOL; PBO; LEM10; LEM5 | Experimental | Drug: LEM5, Drug: LEM10, Drug: ZOL, Drug: PBOParticipants will receive ZOL, PBO, LEM10, and LEM5 in Treatment Periods 1, 2, 3, and 4, respectively. |
| PBO; LEM5; ZOL; LEM10 | Experimental | Drug: LEM5, Drug: LEM10, Drug: ZOL, Drug: PBOParticipants will receive PBO, LEM5, ZOL, and LEM10 in Treatment Periods 1, 2, 3, and 4, respectively. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy, non-smoking female participants, aged 55 years and older, or male participants, aged 65 years and older, at the time of informed consent
- Regular sleep timing and duration, per the following criteria:
- Able to detect a 1000 Hertz (Hz) tone at 20 decibels (dB)
- Able to read English at an 8th-grade level
Key exclusion criteria (26 listed)
- Is a female of childbearing potential Note: All females will be considered to be of childbearing potential unless they are postmenopausal (defined as amenorrheic for at least 12 consecutive months, and are postmenopausal without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- A current diagnosis of insomnia disorder, sleep-related breathing disorder, periodic limb movements disorder (PLMD), restless legs syndrome, circadian rhythm sleep disorder, narcolepsy, sleep-related violent behavior, sleep-driving, sleep-eating, or symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study
- Has subjective sleep onset latency (sSOL) > 20 minutes or subjective wake after sleep onset (sWASO) > 60 minutes on more than 2 nights as reported on the Sleep Diary during the Screening Period before the adaptation night
- Latency to persistent sleep (LPS) longer than 30 minutes as measured on the PSG on the Baseline night (or repeat Baseline night, if needed)
- Has a sleep onset Rapid eye movement (REM) period, defined as first epoch of stage REM within 15 minutes of sleep onset, as measured on the PSG on either the adaptation night or Baseline night (or repeat Baseline night, if needed)
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 |
|---|---|---|
| LEM5Single dose of lemborexant 5 mg administered within 5 minutes before bedtime. | Drug | LEM10; ZOL; LEM5; PBO, LEM5; LEM10; PBO; ZOL, PBO; LEM5; ZOL; LEM10, ZOL; PBO; LEM10; LEM5 |
| LEM10Single dose of lemborexant 10 mg administered within 5 minutes before bedtime. | Drug | LEM10; ZOL; LEM5; PBO, LEM5; LEM10; PBO; ZOL, PBO; LEM5; ZOL; LEM10, ZOL; PBO; LEM10; LEM5 |
| ZOLSingle dose of zolpidem 6.25 mg administered within 5 minutes before bedtime. | Drug | LEM10; ZOL; LEM5; PBO, LEM5; LEM10; PBO; ZOL, PBO; LEM5; ZOL; LEM10, ZOL; PBO; LEM10; LEM5 |
| PBOSingle dose of placebo administered within 5 minutes before bedtime. | Drug | LEM10; ZOL; LEM5; PBO, LEM5; LEM10; PBO; ZOL, PBO; LEM5; ZOL; LEM10, ZOL; PBO; LEM10; LEM5 |
Primary outcome
Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to zolpidem (ZOL) at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Magnitude of body sway upon being awakened at approximately 4 hours after receiving lemborexant 5 milligrams (mg) (LEM5), lemborexant 10 mg (LEM10), zolpidem 6.25 mg, or placebo.
12 secondary outcomes
Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to ZOL and placebo (PBO) at approximately 8 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline in auditory awakening threshold (AAT) for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from power of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from power of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from continuity of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from continuity of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from quality of memory for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from quality of memory for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from speed of memory retrieval for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from speed of memory retrieval for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Number of participants with any serious adverse event and number of participants with any non-serious adverse event
Time frame: up to 72 days
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 1 Aug 2019.
- 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 32022664Murphy P, Kumar D, Zammit G, Rosenberg R, Moline M. Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakening. J Clin Sleep Med. 2020 May 15;16(5):765-773. doi: 10.5664/jcsm.8294. Epub 2020 Feb 6.
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Healthy Participants
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.
4 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 LEM5, LEM10 and ZOL in people with Healthy Subjects, run by Eisai Inc. at 4 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 6 inclusion and 26 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 from time-matched baseline in postural stability for LEM5 and LEM10 compared to zolpidem (ZOL) at approximately 4 hours postdose (time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)). 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 NCT03008447, 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 1 Aug 2019.