A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder (SUNRISE 2)

Eisai Inc.11 sites in 4 countries971 target enrollmentNovember 15, 2016

ConditionsInsomnia Disorder

Interventionslemborexant Placebo

Drugslemborexant Placebo

Overview

Phase: Phase 3
Intervention: lemborexant
Conditions: Insomnia Disorder
Sponsor: Eisai Inc.
Enrollment: 971
Locations: 11
Primary Endpoint: Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia disorder.

Detailed Description

This is a long-term (approximately 1 year), multicenter, randomized, controlled, double-blind, parallel group study of two doses of lemborexant and placebo in approximately 900 male or female participants with insomnia disorder. Approximately 40% of participants will be age 65 years or older. The study will last a maximum of 60 weeks, and will include a Screening Period, an approximately 54-week Treatment Period (during which study medication will be administered), and a 2-week Follow-up Period. All participants will receive lemborexant for at least 6 months and will receive placebo at some point during the study. Participants will not know which medication they receive (lemborexant or placebo) until the study has been completed, and will not know the timings at which the medication will change.

Registry

clinicaltrials.gov

Start Date

November 15, 2016

End Date

January 8, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, age 18 years or older at the time of informed consent
•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
•History of (Subjective Sleep Onset Latency) sSOL ≥30 minutes on at least 3 nights per week in the previous 4 weeks and/or subjective Wake after Sleep Onset (sWASO) ≥60 minutes on at least 3 nights per week in the previous 4 weeks
•History of regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
•Regular bedtime, between 21:00 and 01:00 and regular wake time, the time the participant gets out of bed for the day, between 05:00 and 10:00
•Insomnia Severity Index (ISI) score ≥15

Exclusion Criteria

•A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia.
•STOPBang score greater than or equal to (\>=) 5
•International Restless Legs Scale (IRLS) score \>=16
•Epworth Sleepiness Scale (ESS) score \>15
•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
•Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior, eg, making phone calls, or preparing and eating food while asleep
•For participants who underwent polysomnography (PSG) within the previous year:
•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
•Beck Depression Inventory - II (BDI II) score \>19 at Screening

Arms & Interventions

lemborexant 5 milligrams (mg)

Lemborexant 5 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.

Intervention: lemborexant

lemborexant 10 mg

Lemborexant 10 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.

Intervention: lemborexant

Placebo matched to lemborexant

Lemborexant-matched placebo will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6

Time Frame: Baseline and Month 6

sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.

Secondary Outcomes

Change From Baseline in Subjective Wake After Sleep Onset (sWASO) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6(Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6)
Change From Baseline in Subjective Sleep Efficiency (sSE) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6(Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6)
Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3(Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3)
Change From Baseline in sTST at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6(Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6)
Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 6(Month 6)
Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 12(Month 12)
Change From Baseline in Insomnia Severity Index (ISI) Daytime Functioning Score at Months 1, 3, and 6(Baseline, Months 1, 3, and 6)
Change From Baseline in Fatigue Severity Scale (FSS) Total Score at Months 1, 3 and 6(Baseline, Months 1, 3 and 6)
Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6(Baseline, (mean of 7 nights [approximately Week 1]) in placebo-controlled period, Month 1, 3, 6)
Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Active Treatment Period)(Baseline, First 7 nights (approximately Week 1) in active treatment period)
Change From Screening in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the First and Second 7 Mornings of the Follow-up Period(Screening, First and second 7 mornings in follow-up period (Week 52 to 54))
Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at Months 1, 3, 6, 9 and 12(Baseline, Months 1, 3, 6, 9 and 12)
Rebound Insomnia: Mean sSOL on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period(First 3 nights, first and Last 7 nights of the follow up period (Week 52 to 54))
Rebound Insomnia: Mean sWASO on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period(First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54))
Rebound Insomnia: Percentage of Participants Whose sSOL Was Longer Than at Screening for First 3 Nights of the Follow-up Period, or Whom Mean sSOL Was Longer Than at Screening for First 7 Nights or Last 7 Nights of the Follow-up Period(First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54))
Rebound Insomnia: Percentage of Participants Whose sWASO is Higher Than at Screening for First 3 Nights of the Follow-up Period, or Whose Mean sWASO is Higher Than at Screening for the First 7 Nights or Last 7 Nights of the Follow-up Period(First 3 nights, First and Last 7 nights of the follow up period (Week 52 to 54))
Persistence of Effect: Mean Change From Baseline in sSOL, sWASO, and sTST at Months 3, 6, 9, and 12 Compared to Month 1(Baseline, Month 1, 3, 6, 9, 12)
Persistence of Effect: Mean Change From Baseline in sSE at Months 3, 6, 9, and 12 Compared to Month 1(Baseline, Months 1, 3, 6, 9, and 12)
Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 9 and 12 Compared to Month 7(Baseline, Month 7, 9, 12)
Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSE at Months 9 and 12 Compared to Month 7(Baseline, Month 7, 9, 12)
Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 3 and 6 Exposure Compared to Month 1(Baseline, Month 1, 3, 6)
Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSE at Months 3 and 6 Exposure Compared to Month 1(Baseline, Month 1, 3, 6)