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CompletedNCT03008447Updated Aug 1, 2019

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 interventional study of LEM5 and LEM10 in Healthy Subjects, sponsored by Eisai Inc.. Completed at 4 sites in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-01.

Sponsored by Eisai Inc. · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jan 2018, 8 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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 administration at bedtime.

02

Conditions studied

  • Healthy Subjects

Keywords

  • E2006
  • postural stability
  • auditory awakening threshold
  • cognitive performance
  • healthy participants
03

In context

Lead sponsor

Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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:

    1. 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
    2. 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    LEM5; LEM10; PBO; ZOL

    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).

    Drug: LEM5 · Drug: LEM10 · Drug: ZOL · Drug: PBO

  • Experimental
    LEM10; ZOL; LEM5; PBO

    Participants will receive LEM10, ZOL, LEM5, and PBO in Treatments Periods 1, 2, 3, and 4, respectively.

    Drug: LEM5 · Drug: LEM10 · Drug: ZOL · Drug: PBO

  • Experimental
    ZOL; PBO; LEM10; LEM5

    Participants will receive ZOL, PBO, LEM10, and LEM5 in Treatment Periods 1, 2, 3, and 4, respectively.

    Drug: LEM5 · Drug: LEM10 · Drug: ZOL · Drug: PBO

  • Experimental
    PBO; LEM5; ZOL; LEM10

    Participants will receive PBO, LEM5, ZOL, and LEM10 in Treatment Periods 1, 2, 3, and 4, respectively.

    Drug: LEM5 · Drug: LEM10 · Drug: ZOL · Drug: PBO

Interventions

  • DrugLEM5

    Single dose of lemborexant 5 mg administered within 5 minutes before bedtime.

  • DrugLEM10

    Single dose of lemborexant 10 mg administered within 5 minutes before bedtime.

  • DrugZOL

    Single dose of zolpidem 6.25 mg administered within 5 minutes before bedtime.

  • DrugPBO

    Single dose of placebo administered within 5 minutes before bedtime.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. Number of participants with any serious adverse event and number of participants with any non-serious adverse event

    Time frame: up to 72 days

07

Study locations

4 sites
  • NeuroTrials Research, Inc
    Atlanta, Georgia 30342, United States
  • Clinilabs, Inc
    New York, New York 10019, United States
  • Wake Research Assoicates, LLC
    Raleigh, North Carolina 27612, United States
  • Community Research Management Associates d/b/a CTI Clinical Research Center
    Cincinnati, Ohio 45212, United States
08

References and documents

Publications

  • Murphy 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03008447
Lead sponsor
Eisai Inc.
Collaborators
Purdue Pharma LP
Responsible party
Sponsor
First posted
Jan 2, 2017
Start date
Nov 21, 2016
Primary completion
Jan 3, 2018
Completion
Jan 3, 2018
Last update
Aug 1, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

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