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Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)

Primary Purpose

Delirium

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Suvorexant
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is hospitalized for (1) acute disease with severe disease state or decreased daily living function or (2) elective surgery requiring general anesthesia scheduled on the day after or 2 days after admission/Day 1
  • Has (1) mild cognitive impairment or mild dementia and/or (2) a history of delirium in any prior hospitalization
  • Requires hospitalization for 6 days for acute disease, with treatment starting on day of admission; or 7 days, with treatment starting the day after admission OR
  • Requires hospitalization for 6 days for elective surgery scheduled on the day after admission; or for 7 days for elective surgery scheduled 2 days after admission
  • Is able to take study medications orally

Exclusion Criteria:

  • Has moderate or severe dementia
  • Has a history of epilepsy or Parkinson's disease
  • Currently uses psychotropic agents or has a mental condition including schizophrenia, other mental disorders, bipolar disorder and major depression
  • Has a history of drug or alcohol abuse in the 5 years prior to start of study or has alcoholic disease such as alcoholic liver disease or gastritis alcoholic
  • Has a history of narcolepsy or cataplexy
  • Has used hypnotics, antipsychotics, mood stabilizers, antidepressants, anxiolytics, psychostimulants, anticonvulsants or tiapride within 2 weeks prior to randomization
  • Has delirium as assessed by DSM-5 or DRS-R-98 (total score ≥14.5) before the first dose of study medication

Sites / Locations

  • Kohnodai Hospital, National Center for Global Health and Medicine ( Site 8522)
  • Iizuka Hospital ( Site 8540)
  • Kokura Memorial Hospital ( Site 8537)
  • Maebashi Red Cross Hospital ( Site 8548)
  • Fukuyama City Hospital ( Site 8528)
  • Tonan Hospital ( Site 8512)
  • Kansai Rosai Hospital ( Site 8550)
  • Kanazawa Medical University Hospital ( Site 8514)
  • National Hospital Organization Kanazawa Medical Center ( Site 8554)
  • Kagawa University Hospital ( Site 8519)
  • TAKAMATSU Red Cross Hospital ( Site 8547)
  • Nippon Medical School Musashi Kosugi Hospital ( Site 8502)
  • Showa University Northern Yokohama Hospital ( Site 8534)
  • Yokohama City University Medical Center ( Site 8516)
  • Saiseikai Yokohamashi Nanbu Hospital ( Site 8541)
  • Yokohama City University Hospital ( Site 8515)
  • National Hospital Organization Yokohama Medical Center ( Site 8531)
  • National Hospital Organization Maizuru Medical Center ( Site 8535)
  • Aizawa Hospital ( Site 8542)
  • Matsushita Memorial Hospital ( Site 8556)
  • Osaka University Hospital ( Site 8524)
  • Toyonaka Municipal Hospital ( Site 8521)
  • Shimane Prefectural Central Hospital ( Site 8530)
  • Kamitsuga General Hospital ( Site 8546)
  • SANO KOSEI GENERAL HOSPITAL ( Site 8551)
  • Jichi Medical University Hospital ( Site 8525)
  • Yamaguchi University Hospital ( Site 8517)
  • National Hospital Organization Kyushu Medical Center ( Site 8532)
  • Gifu Municipal Hospital ( Site 8555)
  • Hiroshima City Hiroshima Citizens Hospital ( Site 8505)
  • National Hospital Organization Kumamoto Medical Center ( Site 8511)
  • Japanese Red Cross Kyoto Daini Hospital ( Site 8533)
  • Kyoto Katsura Hospital ( Site 8539)
  • Miyazaki Prefectural Miyazaki Hospital ( Site 8543)
  • Niigata City General Hospital ( Site 8544)
  • Okayama Saiseikai General Hospital ( Site 8549)
  • Okayama University Hospital ( Site 8510)
  • Osaka City General Hospital ( Site 8518)
  • National Hospital Organization Osaka National Hospital ( Site 8536)
  • Japanese Red Cross Osaka Hospital ( Site 8523)
  • Nippon Life Hospital ( Site 8552)
  • Japan Community Health care Organization Osaka Hospital ( Site 8545)
  • Osaka General Medical Center ( Site 8538)
  • Saga-Ken Medical Centre Koseikan ( Site 8526)
  • Tokushima Prefectural Central Hospital ( Site 8509)
  • National Cancer Center Hospital ( Site 8520)
  • National Hospital Organization Tokyo Medical Center ( Site 8529)
  • Tokyo Women's Medical University Hospital ( Site 8527)
  • Juntendo University Nerima Hospital ( Site 8501)
  • Tokyo Medical and Dental University Hospital ( Site 8503)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suvorexant

Placebo

Arm Description

Participants will receive 15 mg of suvorexant orally once daily (QD) for 5 to 7 days.

Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days.

Outcomes

Primary Outcome Measures

Percentage of participants with delirium as assessed by diagnostic and statistical manual of mental disorders 5th edition (DSM-5) criteria
DSM-5 is the gold standard for diagnosis of delirium. DSM-5 criteria will be used for clinician assessment of delirium. The percentage of participants with delirium per DSM-5 criteria will be presented.
Number of participants who experience one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be presented.
Number of participants who discontinue study treatment due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented.

Secondary Outcome Measures

Maximum daily total score on Delirium Rating Scale-Revised-98 (DRS-R-98)
DRS-R-98 is a diagnostic and assessment tool used for evaluation of delirium. It is a 16-item clinician-rated scale with 13 items measuring delirium severity and 3 diagnostic items. The total DRS-R-98 score can range from 0 (lowest) to 46 (highest). Higher scores indicate worsening or more severe delirium. The maximum daily total score on DRS-R-98 will be presented.
Percentage of participants with delirium as assessed by DRS-R-98
DRS-R-98 is a diagnostic and assessment tool used for evaluation of delirium. It is a 16-item clinician-rated scale with 13 items measuring delirium severity and 3 diagnostic items. The total DRS-R-98 score can range from 0 (lowest) to 46 (highest). Higher scores indicate worsening or more severe delirium. Optimized cutoff score for delirium diagnosis in Japanese translated DRS-R-98 has been determined as ≥14.5. The percentage of participants with delirium as assessed by DRS-R-98, defined as the percentage of participants with total score ≥14.5 per DRS-R-98, will be presented.

Full Information

First Posted
September 25, 2020
Last Updated
January 2, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04571944
Brief Title
Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)
Official Title
A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of MK-4305 (Suvorexant) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to evaluate the efficacy and safety of suvorexant (MK-4305) for reducing the incidence of delirium in Japanese participants who are at high risk of delirium. The primary hypothesis is that suvorexant reduces the proportion of participants with delirium compared with placebo as assessed by the diagnostic and statistical manual of mental disorders 5th edition (DSM-5) criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suvorexant
Arm Type
Experimental
Arm Description
Participants will receive 15 mg of suvorexant orally once daily (QD) for 5 to 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days.
Intervention Type
Drug
Intervention Name(s)
Suvorexant
Other Intervention Name(s)
MK-4305
Intervention Description
Suvorexant administered at a dose of 15 mg QD via oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Suvorexant-matching placebo administered QD via oral tablet
Primary Outcome Measure Information:
Title
Percentage of participants with delirium as assessed by diagnostic and statistical manual of mental disorders 5th edition (DSM-5) criteria
Description
DSM-5 is the gold standard for diagnosis of delirium. DSM-5 criteria will be used for clinician assessment of delirium. The percentage of participants with delirium per DSM-5 criteria will be presented.
Time Frame
Up to ~8 days
Title
Number of participants who experience one or more adverse events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be presented.
Time Frame
Up to ~21 days
Title
Number of participants who discontinue study treatment due to an AE
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented.
Time Frame
Up to ~7 days
Secondary Outcome Measure Information:
Title
Maximum daily total score on Delirium Rating Scale-Revised-98 (DRS-R-98)
Description
DRS-R-98 is a diagnostic and assessment tool used for evaluation of delirium. It is a 16-item clinician-rated scale with 13 items measuring delirium severity and 3 diagnostic items. The total DRS-R-98 score can range from 0 (lowest) to 46 (highest). Higher scores indicate worsening or more severe delirium. The maximum daily total score on DRS-R-98 will be presented.
Time Frame
Up to ~8 days
Title
Percentage of participants with delirium as assessed by DRS-R-98
Description
DRS-R-98 is a diagnostic and assessment tool used for evaluation of delirium. It is a 16-item clinician-rated scale with 13 items measuring delirium severity and 3 diagnostic items. The total DRS-R-98 score can range from 0 (lowest) to 46 (highest). Higher scores indicate worsening or more severe delirium. Optimized cutoff score for delirium diagnosis in Japanese translated DRS-R-98 has been determined as ≥14.5. The percentage of participants with delirium as assessed by DRS-R-98, defined as the percentage of participants with total score ≥14.5 per DRS-R-98, will be presented.
Time Frame
Up to ~8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is hospitalized for (1) acute disease with severe disease state or decreased daily living function or (2) elective surgery requiring general anesthesia scheduled on the day after or 2 days after admission/Day 1 Has (1) mild cognitive impairment or mild dementia and/or (2) a history of delirium in any prior hospitalization Requires hospitalization for 6 days for acute disease, with treatment starting on day of admission; or 7 days, with treatment starting the day after admission OR Requires hospitalization for 6 days for elective surgery scheduled on the day after admission; or for 7 days for elective surgery scheduled 2 days after admission Is able to take study medications orally Exclusion Criteria: Has moderate or severe dementia Has a history of epilepsy or Parkinson's disease Currently uses psychotropic agents or has a mental condition including schizophrenia, other mental disorders, bipolar disorder and major depression Has a history of drug or alcohol abuse in the 5 years prior to start of study or has alcoholic disease such as alcoholic liver disease or gastritis alcoholic Has a history of narcolepsy or cataplexy Has used hypnotics, antipsychotics, mood stabilizers, antidepressants, anxiolytics, psychostimulants, anticonvulsants or tiapride within 2 weeks prior to randomization Has delirium as assessed by DSM-5 or DRS-R-98 (total score ≥14.5) before the first dose of study medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Kohnodai Hospital, National Center for Global Health and Medicine ( Site 8522)
City
Ichikawa
State/Province
Chiba
ZIP/Postal Code
272-8516
Country
Japan
Facility Name
Iizuka Hospital ( Site 8540)
City
Iizuka
State/Province
Fukuoka
Country
Japan
Facility Name
Kokura Memorial Hospital ( Site 8537)
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Maebashi Red Cross Hospital ( Site 8548)
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-0811
Country
Japan
Facility Name
Fukuyama City Hospital ( Site 8528)
City
Fukuyama
State/Province
Hiroshima
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
Tonan Hospital ( Site 8512)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0004
Country
Japan
Facility Name
Kansai Rosai Hospital ( Site 8550)
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8511
Country
Japan
Facility Name
Kanazawa Medical University Hospital ( Site 8514)
City
Kahoku-gun
State/Province
Ishikawa
ZIP/Postal Code
920-0293
Country
Japan
Facility Name
National Hospital Organization Kanazawa Medical Center ( Site 8554)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Kagawa University Hospital ( Site 8519)
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
TAKAMATSU Red Cross Hospital ( Site 8547)
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
Nippon Medical School Musashi Kosugi Hospital ( Site 8502)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-8533
Country
Japan
Facility Name
Showa University Northern Yokohama Hospital ( Site 8534)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
224-8503
Country
Japan
Facility Name
Yokohama City University Medical Center ( Site 8516)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Saiseikai Yokohamashi Nanbu Hospital ( Site 8541)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
234-8503
Country
Japan
Facility Name
Yokohama City University Hospital ( Site 8515)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2360064
Country
Japan
Facility Name
National Hospital Organization Yokohama Medical Center ( Site 8531)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
National Hospital Organization Maizuru Medical Center ( Site 8535)
City
Maizuru-shi
State/Province
Kyoto
ZIP/Postal Code
625-8502
Country
Japan
Facility Name
Aizawa Hospital ( Site 8542)
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8510
Country
Japan
Facility Name
Matsushita Memorial Hospital ( Site 8556)
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-8540
Country
Japan
Facility Name
Osaka University Hospital ( Site 8524)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Toyonaka Municipal Hospital ( Site 8521)
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
560-8565
Country
Japan
Facility Name
Shimane Prefectural Central Hospital ( Site 8530)
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8555
Country
Japan
Facility Name
Kamitsuga General Hospital ( Site 8546)
City
Kanuma
State/Province
Tochigi
ZIP/Postal Code
322-8550
Country
Japan
Facility Name
SANO KOSEI GENERAL HOSPITAL ( Site 8551)
City
Sano
State/Province
Tochigi
ZIP/Postal Code
327-8511
Country
Japan
Facility Name
Jichi Medical University Hospital ( Site 8525)
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Yamaguchi University Hospital ( Site 8517)
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 8532)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Gifu Municipal Hospital ( Site 8555)
City
Gifu
ZIP/Postal Code
500-8513
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital ( Site 8505)
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center ( Site 8511)
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daini Hospital ( Site 8533)
City
Kyoto
ZIP/Postal Code
602-8026
Country
Japan
Facility Name
Kyoto Katsura Hospital ( Site 8539)
City
Kyoto
ZIP/Postal Code
615-8256
Country
Japan
Facility Name
Miyazaki Prefectural Miyazaki Hospital ( Site 8543)
City
Miyazaki
ZIP/Postal Code
880-8510
Country
Japan
Facility Name
Niigata City General Hospital ( Site 8544)
City
Niigata
ZIP/Postal Code
950-1197
Country
Japan
Facility Name
Okayama Saiseikai General Hospital ( Site 8549)
City
Okayama
ZIP/Postal Code
700-8511
Country
Japan
Facility Name
Okayama University Hospital ( Site 8510)
City
Okayama
ZIP/Postal Code
7008558
Country
Japan
Facility Name
Osaka City General Hospital ( Site 8518)
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital ( Site 8536)
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Japanese Red Cross Osaka Hospital ( Site 8523)
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Nippon Life Hospital ( Site 8552)
City
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Facility Name
Japan Community Health care Organization Osaka Hospital ( Site 8545)
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Osaka General Medical Center ( Site 8538)
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Saga-Ken Medical Centre Koseikan ( Site 8526)
City
Saga
ZIP/Postal Code
840-8571
Country
Japan
Facility Name
Tokushima Prefectural Central Hospital ( Site 8509)
City
Tokushima
ZIP/Postal Code
770-8539
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 8520)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center ( Site 8529)
City
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital ( Site 8527)
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Juntendo University Nerima Hospital ( Site 8501)
City
Tokyo
ZIP/Postal Code
177-8521
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital ( Site 8503)
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)

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