Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Insomnia

In brief

This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.

Key facts

Study ID

NCT02783729

Run by

Eisai Inc.

People needed

1006

Starts

2016-05-31

Expected to finish

2018-01-30

Last updated by the study team

2024-11-12

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male age 65 years or older or female age 55 years or older at the time of informed consent
• 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
• History of subjective wake after sleep onset (sWASO) typically ≥ 60 minutes on at least 3 nights per week in the previous 4 weeks
• Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
• 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
• Insomnia Severity Index (ISI) score ≥ 13
• Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary before the second screening visit
• Confirmation of regular bedtime and waketime as determined from responses on the Sleep Diary
• Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary
• 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
• Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
• Willing not to start a behavioral or other treatment program for the treatment of insomnia during the participant's participation in the study

You may not qualify if…

• 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:
• STOPBang score ≥5
• International Restless Legs Scale score ≥16
• Epworth Sleepiness Scale score >15 (scores of 11 to 15 require excessive daytime sleepiness to be recorded in participant's Medical History)
• 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
• 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
• Apnea-Hypopnea Index > 15 or Periodic Limb Movement with Arousal Index >15 as measured on the PSG at the second screening visit
• Beck Depression Inventory - II (BDI-II) score >19 at Screening
• Beck Anxiety Index (BAI) score >15 at Screening
• Habitually naps during the day more than 3 times per week
• 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).
• 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.
• History of drug or alcohol dependency or abuse within approximately the previous 2 years
• 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
• Known to be positive for human immunodeficiency virus
• Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
• 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)
• 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 performance assessment battery (PAB). Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded.
• Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
• 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 PAB.
• 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)
• Any suicidal behavior in the past 10 years (per the Suicidal Behavior section of the eC-SSRS)
• Scheduled for surgery during the study
• 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).
• 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)

Where it is running

• PACT — Glendale, Arizona, United States
• Preferred Research Partners — Little Rock, Arkansas, United States
• Study site — Carlsbad, California, United States
• Southern California Research — Fountain Valley, California, United States
• Pacific Sleep Medicine Services — Oceanside, California, United States
• Research Center of Southern California — Oceanside, California, United States
• Orange County Neuropsychiatric Research Center, LLC — Orange, California, United States
• SDS Clinical Trials, Inc. — Orange, California, United States
• Artemis Institute For Clinical Research LLC — San Diego, California, United States
• Pacific Research Network Inc — San Diego, California, United States
• Artemis Institute For Clinical Research — San Marcos, California, United States
• Santa Monica Clinical Trials — Santa Monica, California, United States
• Empire Clinical Research — Upland, California, United States
• PAB Clinical Research — Brandon, Florida, United States
• Saint Francis Sleep Allergy and Lung Institute — Clearwater, Florida, United States
• Fleming Island Center For Clinical Research — Fleming Island, Florida, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• QPS MRA — Hollywood, Florida, United States
• Quest Pharmaceutical Services-Miami Research Associates, LLC (QPS MRA) — Miami, Florida, United States
• Research Centers of America — Oakland Park, Florida, United States
• Compass Research LLC — Orlando, Florida, United States
• NeuroMedical Research Institute — Panama City, Florida, United States
• Clinical Research Group of St Petersburg Inc — St. Petersburg, Florida, United States
• Jasper Summit Research LLC — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

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