Treatment for insomnia disorder MedDRA version: 20.0 Level: LLT Classification code 10078083 Term: Insomnia disorder System Organ Class: 100000004873
Conditions
Sponsors
Eisai Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, age 18 years or older at the time of informed consent 2. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia Disorder, as follows: - Complains of dissatisfaction with nighttime sleep in the form of difficulty getting to sleep, difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep - Frequency of complaint =3 times per week - Duration of complaint =3 months - Associated with complaint of daytime impairment 3. At Screening: History of sSOL =30 minutes on at least 3 nights per week in the previous 4 weeks AND sWASO =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 regular bedtime, defined as the time the subject attempts to sleep, between 21:00 and 01:00 and regular waketime, defined as the time the subject gets out of bed for the day, between 05:00 and 10:00 6. At Screening and Study Baseline: ISI score =15 7. At the 2nd Screening Visit (Visit 2a): Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL =30 minutes on at least 3 of the 7 nights and/or sWASO =60 minutes on at least 3 of the 7 nights 8. At the 2nd Screening Visit (Visit 2a): Confirmation of regular bedtimes and waketimes, as determined from responses on the Sleep Diary completed on a minimum of 7 consecutive mornings between the 1st and 2nd 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 median habitual bedtime or median habitual waketime, respectively, from the Screening Sleep Diary entries 9. At the 2nd Screening Visit (Visit 2a): Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary completed on 7 mornings between the 1st and 2nd screening visit, such that there are not more than 2 nights with duration of time spent in bed 10 hours 10. At Baseline (Visit 3a): Reconfirmation of insomnia symptoms, as determined from responses on the Sleep Diary for the final 7 nights of the Run-in Period, such that sSOL =30 minutes on at least 3 of the 7 nights and/or sWASO =60 minutes on at least 3 of the 7 nights 11. At Baseline (Visit 3a): Reconfirmation of regular bedtimes and waketimes such that the subject has a regular time spent in bed, either sleeping or trying to sleep, between 7 and 10 hours for the final 7 nights of the Run-In Period 12. At Baseline (Visit 3a): Reconfirmation of regular bedtime, defined as the time subject attempts to sleep, between 21:00 and 01:00 and regular waketime, define as the time subject gets out of bed for the day, between 05:00 and 10:00, for the final 7 nights of the Run-in period 13. Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each ni
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 the SDSB as follows: STOPBang score =5, IRLS score =16, ESS score >15 (Scores of 11-15 require excessive daytime sleepiness must be recorded in subject's Medical History) 2. Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicate the need for referral for a diagnostic evaluation for the presence of narcolepsy 3. Reports a history of sleep-related violent behavior, or sleep driving, or anyother complex sleep-related behavior, eg, making phone calls, or preparing and eatingfood while asleep 4. For subjects who underwent diagnostic PSG within 1 year before informed consent: Age 18 to 64 years: Apnea-Hypopnea Index =10, or Periodic Limb Movements with Arousal Index =10; Age =65 years: Apnea-Hypopnea Index >15, or Periodic Limb Movements with Arousal Index >15 5. Beck Depression Inventory – II (BDI-II) score >19 at Screening 6. Beck Anxiety Inventory (BAI) score >15 at Screening 7. Habitually naps more than 3 times per week 8. Females who are breastfeeding or pregnant at Screening or Study Baseline (as documented by a positive serum beta-human chorionic gonadotropin [ß-hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the 1st dose of study drug. 9. Females of childbearing potential who: -Had unprotected sexual intercourse within 30 days before study entry or who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a contraceptive implant, injectable contraceptives, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 10. 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 11. History of drug or alcohol dependency or abuse within approximately the previous 2 years. 16. Current evidence of clinically significant disease (eg, cardiac; respiratory including chronic obstructive pulmonary disease, acute and/or severe respiratory depression; severe hepatic insufficiency; gastrointestinal; renal including severe renal impairment; neurological [including subjects who lack capacity and/or whose cognitive decline indicates disorientation to person/place/ time and/or situation] or 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 subject’s safety or interfere with the study assessments. Subjects for whom a sedating drug would be contraindicated for saf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the efficacy of lemborexant 5 mg (LEM5) and 10 mg (LEM10) compared to placebo (PBO) on subjective sleep onset latency (sSOL) after 6 months of treatment in subjects with insomnia disorder; Secondary Objective: Determine the efficacy of LEM5 and LEM10 compared to PBO on subjective sleep efficiency (sSE) after 6 months of treatment in subjects with insomnia disorder Determine the efficacy of LEM5 and LEM10 compared to PBO on subjective wake after sleep onset (sWASO) after 6 months of treatment in subjects with insomnia disorder ;Primary end point(s): Mean change from Study Baseline in sSOL at Month 6; Timepoint(s) of evaluation of this end point: At Month 6. The sSOL change from Study Baseline to Month 6 will be analyzed using the mixed effect model repeated measurement (MMRM) analysis on the FAS. The model will include all data and will be adjusted for the corresponding Study Baseline value, region, age group (<65 years old; = 65 years old), treatment, time (average of the first 7 nights, Month 1, Month 3, and Month 6) and the interaction of treatment by time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary endpoints: ? Mean change from Study Baseline in sSE at Month 6 ? Mean change from Study Baseline of sWASO at Month 6 Additional Secondary Endpoints: ? Mean change from Study Baseline of sSOL, of sSE, of sWASO and of sTST, at the beginning of treatment (mean of the 7 nights after the 1st dose in Period 1), at Month 1 and at Month 3 ? Mean change from Study Baseline of sTST at Month 6 ? Proportion of responders at Month 6 and Month 12, where sleep onset responder is defined as follows: sSOL at Study Baseline is =30 minutes and mean sSOL at 6 months is =20 minutes, and sleep maintenance responder is defined as follows: sWASO at Study Baseline is =60 minutes and mean sWASO at 6 months is =60 minutes and shows a reduction of >10 minutes compared to Study Baseline. ? Change from Study Baseline in daytime functioning, assessed as the total score from the 4 items on daytime functioning, on the ISI, at Months 1, 3, and 6 ? Change from Study Baseline on the FSS at Months 1, 3, and 6 ? Ratings on the morning sleepiness item of the Sleep Diary, for: - The mean change from Study Baseline of the 1st 7 mornings after the 1st dose in Period 1 and Period 2 - The mean change from Study Baseline at: Month 1, Month 3, and Month 6 - The mean change from Study Baseline and from Period 2 Baseline (as appropriate) for subjects with 1, 3, 6, 9, and 12 months exposure (revised per Amendment 06) - The mean change from Screening for the 1st 7 mornings and 2nd 7 mornings of the Follow-up Period ? Rebound insomnia endpoints as assessed from the Sleep Diary during the Follow- | — |
Countries
Canada, Chile, Finland, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Romania, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactMedical Information
Eisai Ltd.
Outcome results
None listed