emborexant for long-term treatment of insomnia disorder in adults

Phase 1

Conditions: Treatment for insomnia disorder
MedDRA version: 19.0Level: PTClassification code 10022437Term: InsomniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

Registration Number: EUCTR2015-001463-39-ES

Lead Sponsor: Eisai Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 971

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 24:00 and regular waketime, defined as the time the subject gets out of bed for the day, between 05:00 and 09:00
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 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 TIB, 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 TIB duration <7 hours or >9 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 sWASO =60 minutes on at least 3 of the 7 nights
11. At Baseline (Visit 3a): Reconfirmation of regular bedtimes and waketimes as defined in Inclusion Criterion 8, for the final 7 nights of the Run-In Period
12. At Baseline (Visit 3a): Reconfirmation of sufficient duration of TIB as (defined in Inclusion Criterion 9) for the final 7 nights of the Run-In period
13. Willing and able to comply with all aspects of the protocol, including TIB of at least 7 hours each night
14. Willing to not start a behavioral or other treatment program for insomnia during the subject’s participation in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360

Exclusion Criteria

1. A current diagnosis of sleep-related breathing disorder including obstructive sleep apena (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 >10
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. On the MUPS, (a) a history of symptoms of Rapid Eye Movement Behavior Disorder, sleep-related violent behavior, sleep-driving, or sleep-eating, or (b) symptoms of another parasomnia that in the investigator's opinion make the subject unsuitable for the study
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 and 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 safety reasons because of the subject’s occupation or activities are also excluded.
17. Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
18. Any history of a medical or psychiatric condition th

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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