Insomnia MedDRA version: 19.0 Level: PT Classification code 10022437 Term: Insomnia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Suvorexant
Product Code: MK-4305
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SUVOREXANT
Current Sponsor code: MK-4305
Concentration unit: mg milligram(s)
Concentration
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 6.5 hours as confirmed by the central PSG rating. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 235
Exclusion criteria
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 physicia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (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. ;Secondary Objective: 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. ;Primary 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).;Timepoint(s) of evaluation of this end point: End of Week 4 (Visit 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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).;Timepoint(s) of evaluation of this end point: End of Week 4 (Visit 6) | — |
Countries
Australia, Finland, Italy, Korea, Republic of, New Zealand, Peru, Sweden, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Outcome results
None listed