Treatment for insomnia disorder
Conditions
Sponsors
Eisai Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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: o 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 subject is not eligible) o Frequency of complaint = 3 times per week o Duration of complaint = 3 months o Associated with complaint of daytime impairment 3. At Screening: History of subjective WASO (sWASO) typically = 60 minutes on at least 3 nights per week in the previous 4 weeks 4. At Screening: Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours 5. At Screening: Reports habitual bedtime, defined as the time the subject attempts to sleep, between 21:00 and 24:00 and habitual waketime between 05:00 and 09:00 6. At Screening and at check-in before the first PSG during the Run-in Period: ISI score =13 (revised per Amendment 02) 7. Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary on the 7 most recent mornings (minimum 5 of 7 for eligibility) before the second screening visit, such that sWASO = 60 minutes on at least 3 of the 7 nights 8. Confirmation of regular bedtime and waketime as determined from responses on the Sleep Diary on the 7 most recent mornings before the second screening visit, such that neither bedtime, (defined as the time the subject attempts to try to sleep), nor waketime (defined as the time the subject gets out of bed for the day) deviates more than 1 hour on more than 2 nights from the calculated MHB or median habitual waketime, respectively, from the Screening Sleep Diary entries 9. Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary on the 7 most recent mornings before the second screening visit, such that there is not more than 2 nights with time spent in bed duration 10 hours (revised per Amendment 02) 10. During the Run-in Period: Reconfirmation of insomnia symptoms, as determined from responses on the Sleep Diary on the 7 most recent mornings before the first PSG during the Run-in Period, such that sWASO = 60 minutes on at least 3 of the 7 nights 11. During the Run-in Period: Reconfirmation of regular bedtimes and waketimes as defined in Inclusion Criterion 8 12. During the Run-in Period: Reconfirmation of sufficient duration of time spent in bed as defined in Inclusion Criterion 9 (revised per Amendment 02) 13. During the Run-in Period: Objective (PSG) evidence of insomnia as follows: WASO average = 60 minutes on the 2 consecutive PSGs, with neither night < 45 minutes (revised per Amendment 02) 14. Willing and able to comply with all aspects
Exclusion criteria
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: (revised per Amendment 01) a. STOPBang score =5 b. International Restless Legs Scale score =16 c. Epworth Sleepiness Scale score >15 (Scores of 11-15 require excessive daytime sleepiness to be record in subject's medical History) (revised per Amendments 01 and 02) 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 (revised per Amendment 01) 3. On the MUPS, endorsed the item that corresponds to a history of sleep-eating or reports a history of sleep-related violent behaviour, sleep-driving or symptoms of another parasomnia that in the investigator's opinion make the subject unsuitable for the study (revised per Amendment 02) 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 Inventory (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, are in the appropriate age group, and are postmenopausal 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) 9. Excessive caffeine use that in the opinion of the investigator contributes to the subject’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 15. Current evidence of clinically significant disease (eg, cardiac; respiratory including chronic obstructive pulmonary disease, acute and/or severe respiratory depression; gastrointestinal including severe hepatic impairment; renal including severe renal impairment; neurological including myasthenia gravis; psychiatric disease; 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 subject’s safety or interfere with the study assessments, including the ability to perform tasks on the cognitive PAB. Subjects for whom a sedating drug would be contraindicated for safety reasons because of the subject’s occupation or activities are also excluded. (revised per Amendment 01) 16. Comorbid nocturia resulting in f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Demonstrate that lemborexant (LEM10 and LEM5) is superior to PBO on sleep maintenance as assessed by SE after the last 2 nights of treatment Demonstrate that lemborexant (LEM10 and LEM5) is superior to PBO on wake after sleep onset (WASO) after the last 2 nights of treatment ;Primary end point(s): Change from baseline of mean LPS on Days 29 and 30 of LEM10 and LEM5 compared to PBO;Timepoint(s) of evaluation of this end point: LPS on Days 29 and 30 ;Main Objective: Demonstrate using polysomnography (PSG) that lemborexant (LEM10 and LEM5) is superior to placebo (PBO) on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in subjects 55 years and older with insomnia disorder | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline of mean SE on Days 29 and 30 of LEM10 and LEM5 compared to PBO Change from baseline of mean WASO on Days 29 and 30 of LEM10 and LEM5 compared to PBO Additional Secondary Endpoints Change from baseline on the postural stability test of mean units of body sway on Days 2 and 3 of LEM5 and LEM10 compared to ZOL Change from baseline of mean LPS, WASO, and TST on Days 1 and 2 and Days 29 and 30 of LEM5 and LEM10 compared to ZOL Change from baseline mean of subjective Sleep Diary variables including sSOL, sWASO, sSE and sTST over the first 7 and last 7 nights of the Treatment Period of LEM5 and LEM10 compared to ZOL Change from baseline of mean LPS, SE, WASO, WASO2H, and TST on Days 1 and 2 of LEM5 and LEM10 compared to PBO Change from baseline of mean WASO2H and TST on Days 29 and 30 of LEM5 and LEM10 compared to PBO Change from baseline mean of subjective Sleep Diary variables including sSOL, sWASO, sSE and sTST over the first 7 and last 7 nights of the Treatment Period of LEM5 and LEM10 compared to PBO Proportion of responders after Days 1 and 2 and Days 29 and 30 (PSG), and over the first 7 nights and last 7 nights of treatment (Sleep Diary), to LEM5 and LEM10 compared to ZOL and PBO, such that: o Objective sleep onset response is defined as LPS = 20 minutes (provided mean baseline LPS was > 30 minutes) o Subjective sleep onset response is defined as sSOL = 20 minutes (provided mean baseline sSOL was > 30 minutes) o Objective sleep maintenance response is defined as WASO = 60 minutes (provided mean baseline WASO was > 60 minutes and is reduced by > 10 minutes compared to baseline) o Subjective sleep maintenance response is defined as sWASO | — |
Countries
Canada, France, Germany, Italy, Spain, United Kingdom, United States
Contacts
Public ContactMedical Information
Eisai Ltd.
Outcome results
None listed