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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02783729
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
Purdue Pharma LP
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Drug: Lemborexant Drug: Lemborexant-matched placebo Drug: Zolpidem tartrate Drug: Zolpidem-matched placebo Phase 3

Detailed Description:
The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for 30 nights in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. Approximately 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1006 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
Actual Study Start Date : May 31, 2016
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lemborexant 5 milligrams (mg)
Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night
Drug: Lemborexant
Lemborexant 5 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
Other Name: E2006

Drug: Zolpidem-matched placebo
Zolpidem-matched placebo will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.

Experimental: Lemborexant 10 mg
Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night
Drug: Lemborexant
Lemborexant 10 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
Other Name: E2006

Drug: Zolpidem-matched placebo
Zolpidem-matched placebo will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.

Active Comparator: Zolpidem tartrate
Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night
Drug: Lemborexant-matched placebo
Lemborexant-matched placebo be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.

Drug: Zolpidem tartrate
Zolpidem tartrate extended release 6.25 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
Other Name: Ambien CR

Placebo Comparator: Placebo
Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night
Drug: Lemborexant-matched placebo
Lemborexant-matched placebo be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.

Drug: Zolpidem-matched placebo
Zolpidem-matched placebo will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.




Primary Outcome Measures :
  1. Change from baseline in mean latency to persistent to sleep (LPS) of lemborexant 10 milligrams (mg) and lemborexant 5 mg compared to placebo [ Time Frame: Baseline; Days 29 and 30 ]

Secondary Outcome Measures :
  1. Change from baseline in mean sleep efficiency (SE) of lemborexant 10 mg and lemborexant 5 mg compared to placebo for United States (US) participants only [ Time Frame: Baseline; Days 29 and 30 ]
  2. Change from baseline in mean wake after sleep onset (WASO) of lemborexant 10 mg and lemborexant 5 mg compared to placebo for US participants only [ Time Frame: Baseline; Days 29 and 30 ]
  3. Change from baseline in WASO in the second half of the night (WASO2H) of lembrorexant 10 mg and lemborexant 5 mg compared to zolpidem tartrate for US participants only [ Time Frame: Baseline; Days 29 and 30 ]
  4. Change from baseline in mean SE of lemborexant 10 mg and lemborexant 5 mg compared to placebo for non-US participants only [ Time Frame: Baseline; Days 29 and 30 ]
  5. Change from baseline in mean WASO of lemborexant 10 mg and lemborexant 5 mg compared to placebo for non-US participants only [ Time Frame: Baseline; Days 29 and 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male age 65 years or older or female age 55 years or older at the time of informed consent
  2. 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
  3. History of subjective wake after sleep onset (sWASO) typically ≥ 60 minutes on at least 3 nights per week in the previous 4 weeks
  4. Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
  5. 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
  6. Insomnia Severity Index (ISI) score ≥ 13
  7. Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary before the second screening visit
  8. Confirmation of regular bedtime and waketime as determined from responses on the Sleep Diary
  9. Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary
  10. 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

  11. Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
  12. Willing not to start a behavioral or other treatment program for the treatment of insomnia during the participant's participation in the study

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 screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia as follows:

    1. STOPBang score ≥5
    2. International Restless Legs Scale score ≥16
    3. Epworth Sleepiness Scale score >15 (scores of 11 to 15 require excessive daytime sleepiness to be recorded in participant's Medical History)
  2. 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
  3. 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
  4. Apnea-Hypopnea Index > 15 or Periodic Limb Movement with Arousal Index >15 as measured on the PSG at the second screening visit
  5. Beck Depression Inventory - II (BDI-II) score >19 at Screening
  6. Beck Anxiety Index (BAI) score >15 at Screening
  7. Habitually naps during the day more than 3 times per week
  8. 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).
  9. 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.
  10. History of drug or alcohol dependency or abuse within approximately the previous 2 years
  11. 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
  12. Known to be positive for human immunodeficiency virus
  13. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
  14. 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)
  15. 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.
  16. Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
  17. 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.
  18. 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)
  19. Any suicidal behavior in the past 10 years (per the Suicidal Behavior section of the eC-SSRS)
  20. Scheduled for surgery during the study
  21. 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).
  22. 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)
  23. 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
  24. Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline, or plans to travel across more than 3 time zones during the study
  25. A positive drug test at Screening, Run-In, or Baseline, or unwilling to refrain from use of recreational drugs during the study
  26. Hypersensitivity to lemborexant or zolpidem or to their excipients
  27. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5× the half-life, whichever is longer preceding informed consent
  28. 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): NCT02783729


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Locations
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United States, Alabama
Jasper Summit Research LLC
Jasper, Alabama, United States, 35501
United States, Arizona
PACT
Glendale, Arizona, United States, 85306
United States, Arkansas
Preferred Research Partners
Little Rock, Arkansas, United States, 72211
United States, California
Carlsbad, California, United States, 92011
Southern California Research
Fountain Valley, California, United States, 92708
Pacific Sleep Medicine Services
Oceanside, California, United States, 92054
Research Center of Southern California
Oceanside, California, United States, 92056
Orange County Neuropsychiatric Research Center, LLC
Orange, California, United States, 92868
SDS Clinical Trials, Inc.
Orange, California, United States, 92868
Artemis Institute For Clinical Research LLC
San Diego, California, United States, 92103
Pacific Research Network Inc
San Diego, California, United States, 92103
Artemis Institute For Clinical Research
San Marcos, California, United States, 92078
Santa Monica Clinical Trials
Santa Monica, California, United States, 90404
Empire Clinical Research
Upland, California, United States, 91786
United States, Florida
PAB Clinical Research
Brandon, Florida, United States, 33511
Saint Francis Sleep Allergy and Lung Institute
Clearwater, Florida, United States, 33765
Fleming Island Center For Clinical Research
Fleming Island, Florida, United States, 32003
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
MD Clinical
Hallandale Beach, Florida, United States, 33009
QPS MRA
Hollywood, Florida, United States, 33024
Quest Pharmaceutical Services-Miami Research Associates, LLC (QPS MRA)
Miami, Florida, United States, 33143
Research Centers of America
Oakland Park, Florida, United States
Compass Research LLC
Orlando, Florida, United States, 32806
NeuroMedical Research Institute
Panama City, Florida, United States, 32405
Clinical Research Group of St Petersburg Inc
Saint Petersburg, Florida, United States, 33707
United States, Georgia
NeuroTrials Research Inc.
Atlanta, Georgia, United States, 30342
SleepCare Research Institute Inc
Stockbridge, Georgia, United States, 30281
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Chicago Research Center Inc
Chicago, Illinois, United States, 60634
United States, Maryland
Helene A Emsellem MD PC
Chevy Chase, Maryland, United States, 20815
Sleep Disorders Center of the Mid-Atlantic
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Neurocare Inc
Newton, Massachusetts, United States, 02459
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Novi, Michigan, United States, 48377
Clinical Neurophysiology Services
Sterling Heights, Michigan, United States, 48314
United States, Missouri
St. Louis Clinical Trials
Saint Louis, Missouri, United States, 63141
Clayton Sleep Institute
Saint Louis, Missouri, United States, 63143
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89104
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
CLINiLABS, Inc.
Eatontown, New Jersey, United States, 07724
United States, New York
Winthrop University Hospital
Garden City, New York, United States, 11530
Clinical Research Unit
New York, New York, United States, 10019
University of Rochester
Rochester, New York, United States, 14642
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
Sleep Medicine Centers of Western New York
West Seneca, New York, United States, 14224
United States, North Carolina
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
Wilmington Health Associates
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati, Ohio, United States, 45212
Intrepid Research
Cincinnati, Ohio, United States, 45245
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45255
Ohio Sleep Medicine Institute
Dublin, Ohio, United States, 43017
Cleveland Sleep Research Center
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-3309
United States, South Carolina
Medical University of South Carolina - PPDS
Charleston, South Carolina, United States, 29425
Sleepmed of South Carolina
Columbia, South Carolina, United States, 29201
United States, Texas
Pioneer Research Solutions
Houston, Texas, United States, 77099
United States, Virginia
Sleep Disorders Center of the Mid-Atlantic
Vienna, Virginia, United States, 22182
United States, Washington
Seattle, Washington, United States, 98101
Swedish Medical Center
Seattle, Washington, United States, 98122
Canada, Alberta
Sleep and Fatigue Institute
Calgary, Alberta, Canada
Canada, British Columbia
Medical Arts Health Research Group
Kelowna, British Columbia, Canada
Canada, Ontario
Markham, Ontario, Canada, L3R 1A3
Somni Research Inc.
Markham, Ontario, Canada
Tri Hospital Sleep West
Mississauga, Ontario, Canada
Sleep Wake Disorders Clinic
Scarborough, Ontario, Canada
Toronto, Ontario, Canada, M4P 1P2
Toronto Sleep Institute
Toronto, Ontario, Canada
France
Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
Bordeaux, France
Hopital Gabriel Montpied
Clermont-ferrand, France
CHU Dijon Bourgogne
Dijon Cedex, France
Hôtel Dieu de Paris Hospital
Paris, France
Hopital Civil
Strasbourg, France
Germany
Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Württemberg, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Advanced Sleep Research GmbH
Berlin, Germany
Emovis GmbH
Berlin, Germany
Studienzentrum Wilhelmshöhe
Kassel, Germany
Klinikum rechts der Isar der Technischen Universität München
München, Germany
Universitätsklinikum Münster
Münster, Germany
Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Germany
Italy
Ospedale Bellaria
Bologna, Emilia-Romagna, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardia, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Fondazione PTV Policlinico Tor Vergata
Roma, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy
Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain
Hospital Clinic de Barcelona
Badalona, Spain
Barcelona, Spain, 08025
Clinica del Son Estivill
Barcelona, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain
Hospital San Rafael
La Coruña, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Instituto de Investigaciones del Sueño
Madrid, Spain
Hospital Universitario Araba - Txagorritxu
Vitória, Spain
United Kingdom
Papworth Hospital
Cambridge, Cambridge Shire, United Kingdom
University of Surrey
Guildford, Surrey, United Kingdom
Guys Hospital
London, United Kingdom
Royal Stoke University Hospital
Stoke on Trent, United Kingdom
Sponsors and Collaborators
Eisai Inc.
Purdue Pharma LP

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02783729     History of Changes
Other Study ID Numbers: E2006-G000-304
2015-004347-39 ( EudraCT Number )
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: March 2018

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

Keywords provided by Eisai Inc.:
E2006
Lemborexant
zolpidem tartrate
Ambien CR
Insomnia

Additional relevant MeSH terms:
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Zolpidem
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action