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Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)

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ClinicalTrials.gov Identifier: NCT02952820
Recruitment Status : Active, not recruiting
First Posted : November 2, 2016
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Purdue Pharma LP
Information provided by (Responsible Party):
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Insomnia Disorder Drug: lemborexant Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 15, 2016
Estimated Primary Completion Date : December 19, 2018
Estimated Study Completion Date : December 19, 2018

Arm Intervention/treatment
Experimental: 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.
Drug: lemborexant
Drug: Placebo
Experimental: 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.
Drug: lemborexant
Drug: Placebo
Placebo Comparator: 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.
Drug: lemborexant
Drug: Placebo



Primary Outcome Measures :
  1. Mean change in Subjective Sleep Onset Latency (sSOL) [ Time Frame: Beginning of placebo-controlled treatment; 6 months of placebo-controlled treatment ]

Secondary Outcome Measures :
  1. Mean change in Subjective Sleep Efficiency (sSE) [ Time Frame: Beginning of placebo-controlled treatment; 6 months of placebo-controlled treatment ]
  2. Mean change in Subjective Wake after Sleep Onset (sWASO) [ Time Frame: Beginning of placebo-controlled treatment; 6 months of placebo-controlled treatment ]
  3. Mean change in sSOL, sWASO, and Subjective Total Sleep Time (sTST) as measured in minutes [ Time Frame: Beginning of placebo-controlled treatment; 1 month and 3 months of placebo-controlled treatment ]
  4. Mean change in sSE after 1 months and 3 months of placebo-controlled treatment [ Time Frame: Beginning of placebo-controlled treatment; 1 month and 3 months of placebo-controlled treatment ]
  5. Mean change in sTST [ Time Frame: Beginning of placebo-controlled treatment; 6 months of placebo-controlled treatment ]
  6. Number of Sleep Onset Responders and Sleep Maintenance Responders at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
  7. Change in daytime functioning, assessed as the total score and on the 4 Items on Daytime Functioning, on the Insomnia Severity Index (ISI), at the End of 1, 3, and 6 Months of placebo-controlled treatment [ Time Frame: Beginning of placebo-controlled treatment; 1, 3, and 6 months of placebo-controlled treatment ]
  8. Change on the Fatigue Severity Scale (FSS) at the end of 1, 3, and 6 months of placebo-controlled treatment [ Time Frame: Beginning of placebo-controlled treatment; 1, 3, and 6 months of placebo-controlled treatment ]
  9. Mean Change in Ratings of Morning Sleepiness Item of the Sleep Dairy from Study Baseline on the first 7 mornings of active treatment, and at Months 1, 3, 6, 9, and 12 (as appropriate) [ Time Frame: Study Baseline; first 7 mornings of active treatment, and at Months 1, 3, 6, 9, and 12 (as appropriate) ]
  10. Mean change from screening in ratings of morning sleepiness item of the sleep dairy for the first 7 mornings and the second 7 mornings of the follow up Period [ Time Frame: Screening; Week 1 and 2 of Follow-up period (2 weeks after 12 months of treatment) ]
  11. Change from Screening of sSOL on each of the first 3 nights, mean sSOL of the first 7 nights, and mean sSOL of the second 7 nights of the Follow up Period [ Time Frame: Screening; Days 1-3, Week 1 and Week 2 of follow-up period (2 weeks after 12 months of treatment) ]
  12. Change from Screening of sWASO on each of the first 3 nights of the Follow-up Period, mean sWASO of the first 7 nights and mean sWASO of the second 7 nights of the Follow-up Period [ Time Frame: Screening; Days 1-3, Week 1 and Week 2 of follow-up period (2 weeks after 12 months of treatment) ]
  13. Percentage of participants whose sSOL is longer than at Screening for each of the first 3 nights of the Follow-up Period, or whose mean sSOL is longer than at Screening for first 7 nights or second 7 nights of the Follow-up Period [ Time Frame: Screening, Days 1-3, Week 1 and Week 2 of follow-up period (2 weeks after 12 months of treatment) ]
  14. Percentage of participants whose sWASO is higher than at Screening for each of the first 3 nights of the Follow-up Period, or whose mean sWASO is higher than at Screening for the first 7 nights or second 7 nights of the Follow-up Period [ Time Frame: Screening, Days 1-3, Week 1 and Week 2 of follow-up period (2 weeks after 12 months of treatment) ]
  15. Mean change from baseline (as appropriate) in sSOL, sWASO, and sTST as measured in minutes at Months 3, 6, 9, and 12 compared to Month 1 of active treatment [ Time Frame: Baseline and Months 1, 3, 6, 9, and 12 of active treatment (as appropriate) ]
  16. Mean change from baseline (as appropriate) in sSE at Months 3, 6, 9, and 12 compared to Month 1 of active treatment [ Time Frame: Baseline and Months 1, 3, 6, 9, and 12 of active treatment (as appropriate) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Confirmation of current insomnia symptoms as determined from 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
  • Confirmation of time spent in bed, as determined from on the Sleep Diary completed on 7 mornings between the first and second screening visit, such that there are not more than 2 nights with duration of time spent in bed 7 hours and 10 hours
  • Confirmation of regular bedtimes and wake times such that the participant 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 before visit 3.
  • Confirmation of regular bedtime between 21:00 and 01:00 and time of getting out of bed for the day between 05:00 and 10:00 for the final 7 nights of the before visit 3.
  • Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
  • Willing to not start a behavioral or other treatment program for insomnia during the participants participation in the study

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.

    • 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
  • Beck Anxiety Inventory (BAI) score >15 at Screening
  • Habitually naps more than 3 times per week
  • Females who are breastfeeding or pregnant at Screening or Study Baseline
  • Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.)
  • 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
  • A prolonged QT/QT interval corrected by Fridericia's formula (QTcF >450 ms) as demonstrated by a repeated electro cardiogram(ECG) at Screening (repeated only if initial ECG indicates a QTcF interval >450 ms)
  • Current evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal, neurological [including participants who lack capacity and/or whose cognitive decline indicates disorientation to person/place/time and/or situation], or psychiatric disease or malignancy other than 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
  • Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
  • Scheduled for major surgery during the study
  • Used any prohibited prescription or over-the-counter concomitant medications within 1 week before the first dose of study medication
  • Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 2 weeks before Screening
  • Failed treatment with suvorexant (Belsomra®) (efficacy and/or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator
  • Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Study Baseline
  • Previously participated in any clinical trial of lemborexant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952820


  Show 114 Study Locations
Sponsors and Collaborators
Eisai Inc.
Purdue Pharma LP
Investigators
Study Director: Eisai Medical Information Eisai Inc.

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02952820     History of Changes
Other Study ID Numbers: E2006-G000-303
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Eisai Inc.:
insomnia

Additional relevant MeSH terms:
Disease
Sleep Initiation and Maintenance Disorders
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders