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    Summary
    EudraCT Number:2015-003154-40
    Sponsor's Protocol Code Number:MK-4305-061
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-003154-40
    A.3Full title of the trial
    A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Subjects with Alzheimer’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of suvorexant (MK-4305) for the treatment of insomnia in AD subjects
    A.3.2Name or abbreviated title of the trial where available
    Safety&Efficacy of suvorexant for treatment of insomnia in AD subjects
    A.4.1Sponsor's protocol code numberMK-4305-061
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02750306
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name Suvorexant
    D.3.2Product code MK-4305
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSUVOREXANT
    D.3.9.2Current sponsor codeMK-4305
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSuvorexant
    D.3.2Product code MK-4305
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSUVOREXANT
    D.3.9.2Current sponsor codeMK-4305
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Insomnia
    E.1.1.1Medical condition in easily understood language
    Insomnia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10022437
    E.1.2Term Insomnia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (1) To evaluate the efficacy of suvorexant compared with placebo in improving insomnia, as measured by change from baseline in PSG-derived total sleep time (TST), at Week 4.
    (2) To evaluate the safety and tolerability of suvorexant for up to 4 weeks of treatment.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of suvorexant compared with placebo in improving insomnia as measured by change from baseline in PSG-derived wakefulness after persistent sleep onset (WASO), at Week 4.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    1. Be between 50 to 90 years of age (inclusive) on the day of signing informed consent.
    2. Meet the criteria for a diagnosis of probable Alzheimer’s disease based on either a) the National Institute on Aging – Alzheimer’s Association (NIA-AA) criteria or b) the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, (DSM-5) criteria for AD.
    3. Have a Mini Mental State Examination score ≥ 12 and ≤ 26 at Screening.
    4. Have a DSM-5 diagnosis of insomnia based on the investigator’s judgment and by the subject’s sleep history.
    5. Be willing to stay overnight at a sleep laboratory and stay in bed for at least 8 hours for PSG testing.
    6. Have a regular bedtime between 8 PM (20:00) and 1 AM (01:00) and is willing to maintain it for the duration of the trial.
    7. Be able and willing to wear an activity/sleep watch on the wrist throughout the day and night.
    8. Each subject (or legal representative) must sign the informed consent form.
    9. Based on the investigator's judgment (with legal representative input, as applicable), the subject should: be able to speak, read, and understand the language of the trial staff and the informed consent form; possess the ability to respond verbally to questions, follow instructions, and complete study assessments; be able to adhere to dose and visit schedules.
    10. Have a reliable and competent trial partner (e.g., spouse, family member, or other caregiver) who meets the trial requirements and obligations.
    11. Have results of clinical laboratory tests (complete blood count [CBC], blood chemistries, thyroid function tests, and urinalysis) within normal limits or clinically acceptable to the investigator at Screening.
    12. Have results of a physical examination (PE), including neurological exam, vital signs, and ECG and clinical laboratory tests (Bazett’s correction) within normal limits (based on the population under study, i.e. Alzheimer’s Disease and insomnia) or clinically acceptable based on investigator judgment at Screening.
    13. If female, not be of childbearing potential.
    14. Be willing to provide a blood sample for APOE genotyping.
    15. Have a mean TST < 6 hours on the combined Screening (Visit 2) and Baseline (Visit 3) PSGs, where neither night is > 6.5 hours as confirmed by the central PSG rating.
    E.4Principal exclusion criteria
    1. Resides in a nursing home (or similar institutional facility).
    2. Evidence of vascular dementia ( based on Modified Hachinski Ischemia Scale Score.
    3. Has a known history of stroke that confounds the diagnosis of AD or insomnia.
    4. Has evidence of a clinically relevant neurological disorder other than probable AD, including but not limited to: vascular dementia, parkinsonism, frontotemporal dementia, Huntington's disease, amyotrophiclateral sclerosis, multiple sclerosis, progressive supranuclear palsy, neurosyphilis, dementia with Lewy bodies, other types of dementia, mental retardation, hypoxic
    cerebral damage, cognitive impairment due to other disorders,
    5. Has a history of seizures or epilepsy within the last 5 years before Screening.
    6. Has a history or diagnosis of sleep disorders other than insomnia .
    7. Has a clinically significant movement disorder that would affect the activity/sleep watch and wakefulness.
    8. In the opinion of the investigator, has difficulty sleeping primarily due to a confounding medical condition.
    9. Has a current episode of major depression based on investigator's judgment.
    10. Has any of the following based on clinician interview and DSM-5 criteria: lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder; or, a psychiatric condition requiring treatment with a prohibited medication; or other psychiatric condition that would interfere with the subject’s ability to participate in the study.
    11. Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale .
    12. Has a history of alcoholism or drug dependency/abuse within the last 5 years of Screening.
    13. Has a recent history (within the 6 months prior to Screening) of regular consumption (3 or more days per week) of either:
    • More than 2 alcoholic beverages per day or alcohol consumption within 3 hours prior to bedtime.
    • More than > 600 mg caffeine a day (e.g., 4 standard 8-ounce cups of brewed coffee, See Appendix 12.7 for a list of caffeinated products) or consumes caffeine after 4pm (16:00).
    14. Has a history of excessive daytime napping.
    15. Has a recent or ongoing, uncontrolled, clinically significant medical condition or major surgery where participation in the trial would pose a significant medical risk.
    16. Has confirmed abnormal pre-randomization laboratory values per the guidance below or other clinically significant, unexplained laboratory abnormality in the opinion of the investigator:
    • Alanine transaminase (SGPT or ALT) ≥ 3 x the upper limit of normal (≥ 3 x ULN)
    • Aspartate transaminase (SGOT or AST) ≥ 3 x ULN
    • Total bilirubin ≥ 1.5 x ULN
    17. Has a vitamin B12 or folate deficiency, abnormal thyroid function tests
    18. Has a history of hypersensitivity or idiosyncratic reaction to more than three (3) chemical classes of drugs, including prescriptions and over-the-counter medications.
    19. Has donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate or receive blood products during participation in the study.
    20. Has a history of malignancy within 5 years except for adequately treated basal or squamous cell skin cancer; in situ cervical cancer; localized prostate carcinoma; who has undergone potentially curative therapy with no evidence of recurrence for ≥ 3 year post-therapy, and who is deemed at low risk for recurrence by her/his treating physician.
    21. Is pregnant, is attempting to become pregnant, or is nursing children.
    22. Body Mass Index > 40 kg/m2.
    23. Is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
    24. Family member (e.g., spouse, parent/legal guardian, sibling or child) is investigational site or sponsor staff directly involved with this trial.
    25. Is taking, or plans to take a prohibited medication that cannot be safely discontinued.
    26. Underlying pathology of sleep, identified and confirmed by PSG, during the Visit 2 Screening PSG.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is total sleep time (TST) as measured in the sleep laboratory by PSG during an 8 –hour recording period beginning at the subject’s habitual bedtime, at Week 4 (minutes).
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Week 4 (Visit 6)
    E.5.2Secondary end point(s)
    The secondary endpoint for this study is wakefulness after persistent sleep onset (WASO) as measured in the sleep laboratory by PSG during an 8-hour recording period beginning at the subject’s habitual bedtime, at Week 4 (minutes).
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Week 4 (Visit 6)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Finland
    Italy
    Korea, Republic of
    New Zealand
    Peru
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 235
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects with Alzheimer’s disease
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 260
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the trial completes any future treatment and care for patients with insomnia and Alzheimer's disease will be provided according to the local standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-30
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