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Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder

This study is currently recruiting participants.
Verified September 2017 by Eisai Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02783729
First Posted: May 26, 2016
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Purdue Pharma LP
Information provided by (Responsible Party):
Eisai Inc.
May 24, 2016
May 26, 2016
September 20, 2017
May 2016
November 2017   (Final data collection date for primary outcome measure)
Change from baseline in mean wake after sleep onset in the second half of the night (WASO2H) of lemborexant 10 milligrams (mg) compared to zolpidem tartrate 6.25 mg [ Time Frame: Day 29 and 30 ]
Same as current
Complete list of historical versions of study NCT02783729 on ClinicalTrials.gov Archive Site
  • Change from baseline in WASO2H of lemborexant 5 mg compared to zolpidem tartrate 6.25 mg [ Time Frame: Day 29 and 30 ]
  • Change from baseline in the postural stability test of mean units of body sway of lemborexant 5 mg and lemborexant 10 mg compared to zolpidem tartrate 6.25 mg [ Time Frame: Day 2 and 3 ]
Same as current
Not Provided
Not Provided
 
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder
The primary objective of this study is to demonstrate using polysomnography (PSG) that 10 mg lemborexant is superior to zolpidem tartrate extended release 6.25 mg (Ambien CR®) on objective sleep maintenance as assessed by wake after sleep onset in the second half of the night (WASO2H) after the last 2 nights of treatment in participants 55 years and older with insomnia disorder.
The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for approximately 6 weeks in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. At least 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Insomnia
  • Drug: Lemborexant
    Lemborexant 5 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
    Other Name: E2006
  • Drug: Lemborexant
    Lemborexant 10 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
    Other Name: E2006
  • Drug: Lemborexant-matched placebo
    Lemborexant-matched placebo be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
  • Drug: Zolpidem tartrate
    Zolpidem tartrate extended release 6.25 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
    Other Name: Ambien CR
  • Drug: Zolpidem-matched placebo
    Zolpidem-matched placebo will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
  • Experimental: Lemborexant 5 milligrams (mg)
    Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night
    Interventions:
    • Drug: Lemborexant
    • Drug: Zolpidem-matched placebo
  • Experimental: Lemborexant 10 mg
    Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night
    Interventions:
    • Drug: Lemborexant
    • Drug: Zolpidem-matched placebo
  • Active Comparator: Zolpidem tartrate
    Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night
    Interventions:
    • Drug: Lemborexant-matched placebo
    • Drug: Zolpidem tartrate
  • Placebo Comparator: Placebo
    Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night
    Interventions:
    • Drug: Lemborexant-matched placebo
    • Drug: Zolpidem-matched placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
950
November 2017
November 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. Male age 65 years or older or female age 55 years or older at the time of informed consent
  2. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for Insomnia Disorder, as follows:

    • Complains of dissatisfaction with nighttime sleep, in the form of difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep (Note that if the complaint is limited to difficulty initiating sleep, the participant is not eligible)
    • Frequency of complaint ≥ 3 times per week
    • Duration of complaint ≥ 3 months
    • Associated with complaint of daytime impairment
  3. History of subjective wake after sleep onset (sWASO) typically ≥ 60 minutes on at least 3 nights per week in the previous 4 weeks
  4. Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
  5. Reports habitual bedtime, defined as the time the participant attempts to sleep, between 21:00 and 24:00 and habitual waketime between 05:00 and 09:00
  6. Insomnia Severity Index (ISI) score ≥ 13
  7. Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary before the second screening visit
  8. Confirmation of regular bedtime and waketime as determined from responses on the Sleep Diary
  9. Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary
  10. Objective (polysomnography [PSG]) evidence of insomnia as follows:

    a) Wake after sleep onset (WASO) average ≥ 60 minutes on the 2 consecutive PSGs, with neither night < 45 minutes

  11. Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
  12. Willing not to start a behavioral or other treatment program for the treatment of insomnia during the participant's participation in the study

Exclusion Criteria

  1. A current diagnosis of sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] treatment), 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 as follows:

    1. STOPBang score ≥5
    2. International Restless Legs Scale score ≥16
    3. Epworth Sleepiness Scale score >15 (scores of 11 to 15 require excessive daytime sleepiness to be recorded in participant's Medical History)
  2. Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy
  3. On the Munich Parasomnia Scale (MUPS), endorsed the item that corresponds to a history of sleep-eating or reports a history of sleep-related violent behavior, sleep-driving, or symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study
  4. Apnea-Hypopnea Index > 15 or Periodic Limb Movement with Arousal Index >15 as measured on the PSG at the second screening visit
  5. Beck Depression Inventory - II (BDI-II) score >19 at Screening
  6. Beck Anxiety Index (BAI) score >15 at Screening
  7. Habitually naps during the day more than 3 times per week
  8. 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).
  9. Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study.
  10. History of drug or alcohol dependency or abuse within approximately the previous 2 years
  11. Reports habitually consuming more than 14 drinks containing alcohol per week (females) or more than 21 drinks containing alcohol per week (males), or unwilling to limit alcohol intake to no more than 2 drinks per day or forego having alcohol within the 3 hours before bedtime for the duration of his/her participation in the study
  12. Known to be positive for human immunodeficiency virus
  13. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
  14. A prolonged QT/QTcF interval (QTcF >450 milliseconds [ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening (repeated only if initial ECG indicates a QTcF interval >450 ms)
  15. Current evidence of clinically significant disease (e.g., cardiac; respiratory including chronic obstructive pulmonary disease, acute and/or severe respiratory depression; gastrointestinal; severe hepatic impairment; renal including severe renal impairment; neurological including myasthenia gravis; psychiatric disease; or malignancy within the past 5 years other than adequately treated basal cell carcinoma) or chronic pain that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments, including the ability to perform tasks on the cognitive PAB. Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded.
  16. Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
  17. Any history of a medical or psychiatric condition that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessment, including the ability to perform the performance assessment battery (PAB).
  18. Any suicidal ideation with intent with or without a plan, at the time of or within 6 months before the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) administration during the Prerandomization Phase (i.e., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the eC-SSRS)
  19. Any suicidal behavior in the past 10 years (per the Suicidal Behavior section of the eC-SSRS)
  20. Scheduled for surgery during the study
  21. Used any prohibited prescription or over-the-counter concomitant medications within 1 week or 5 half lives, whichever is longer, before the first dose of study medication (Run-in Period).
  22. Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 1 week or 5 half-lives, whichever is longer, before the first dose of study medication (Run-in Period)
  23. Failed treatment with suvorexant (Belsomra®) (efficacy and/or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator
  24. Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline, or plans to travel across more than 3 time zones during the study
  25. A positive drug test at Screening, Run-In, or Baseline, or unwilling to refrain from use of recreational drugs during the study
  26. Hypersensitivity to lemborexant or zolpidem or to their excipients
  27. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5× the half-life, whichever is longer preceding informed consent
  28. Previously participated in any clinical trial of lemborexant
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com
Canada,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT02783729
E2006-G000-304
2015-004347-39 ( EudraCT Number )
No
Not Provided
Not Provided
Eisai Inc.
Eisai Inc.
Purdue Pharma LP
Not Provided
Eisai Inc.
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP