Trial Outcomes & Findings for Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085) (NCT NCT04571944)
NCT ID: NCT04571944
Last Updated: 2024-11-25
Results Overview
The DSM-5 is the gold standard for the diagnosis of delirium. DSM-5 criteria were used for clinician assessment of delirium. The percentage of participants with delirium per DSM-5 criteria is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
207 participants
Primary outcome timeframe
Up to ~8 days
Results posted on
2024-11-25
Participant Flow
Participant milestones
| Measure |
Suvorexant
Participants received 15 mg of suvorexant orally once daily (QD) for 5 to 7 days.
|
Placebo
Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
102
|
|
Overall Study
COMPLETED
|
99
|
102
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
Suvorexant
Participants received 15 mg of suvorexant orally once daily (QD) for 5 to 7 days.
|
Placebo
Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
One participant canceled surgery and one participant developed delirium before the first dose.
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)
Baseline characteristics by cohort
| Measure |
Suvorexant
n=105 Participants
Participants received 15 mg of suvorexant orally once daily (QD) for 5 to 7 days.
|
Placebo
n=102 Participants
Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days.
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81.5 Years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
82.0 Years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
81.7 Years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
105 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to ~8 daysPopulation: All randomized participants who had at least one assessment of delirium by DSM-5 following administration of at least one dose of study treatment
The DSM-5 is the gold standard for the diagnosis of delirium. DSM-5 criteria were used for clinician assessment of delirium. The percentage of participants with delirium per DSM-5 criteria is presented.
Outcome measures
| Measure |
Suvorexant
n=101 Participants
Participants received 15 mg of suvorexant orally QD for 5 to 7 days.
|
Placebo
n=102 Participants
Participants received suvorexant-matching placebo orally QD for 5 to 7 days.
|
|---|---|---|
|
Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria
|
16.8 Percentage of participants
|
26.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to ~21 daysPopulation: All randomized participants who received at least one dose of study treatment
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 experienced one or more AEs is presented.
Outcome measures
| Measure |
Suvorexant
n=101 Participants
Participants received 15 mg of suvorexant orally QD for 5 to 7 days.
|
Placebo
n=102 Participants
Participants received suvorexant-matching placebo orally QD for 5 to 7 days.
|
|---|---|---|
|
Number of Participants Who Experienced One or More Adverse Events (AEs)
|
86 Participants
|
86 Participants
|
PRIMARY outcome
Timeframe: Up to ~7 daysPopulation: All randomized participants who received at least one dose of study treatment
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 discontinued study treatment due to an AE is presented.
Outcome measures
| Measure |
Suvorexant
n=101 Participants
Participants received 15 mg of suvorexant orally QD for 5 to 7 days.
|
Placebo
n=102 Participants
Participants received suvorexant-matching placebo orally QD for 5 to 7 days.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to ~8 daysPopulation: All randomized participants who had at least one assessment of delirium by DSM-5 following administration of at least one dose of study treatment
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 is presented.
Outcome measures
| Measure |
Suvorexant
n=101 Participants
Participants received 15 mg of suvorexant orally QD for 5 to 7 days.
|
Placebo
n=102 Participants
Participants received suvorexant-matching placebo orally QD for 5 to 7 days.
|
|---|---|---|
|
Maximum Daily Total Score on Delirium Rating Scale-Revised-98 (DRS-R-98)
|
7.0 Score on a scale
Interval 4.0 to 13.0
|
7.5 Score on a scale
Interval 4.0 to 16.0
|
SECONDARY outcome
Timeframe: Up to ~8 daysPopulation: All randomized participants who had at least one assessment of delirium by DSM-5 following administration of at least one dose of study treatment
DRS-R-98 is a diagnostic and assessment tool used for the 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, is presented.
Outcome measures
| Measure |
Suvorexant
n=101 Participants
Participants received 15 mg of suvorexant orally QD for 5 to 7 days.
|
Placebo
n=102 Participants
Participants received suvorexant-matching placebo orally QD for 5 to 7 days.
|
|---|---|---|
|
Percentage of Participants With Delirium as Assessed by DRS-R-98
|
17.8 Percentage of participants
|
26.5 Percentage of participants
|
Adverse Events
Suvorexant
Serious events: 6 serious events
Other events: 64 other events
Deaths: 1 deaths
Placebo
Serious events: 6 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Suvorexant
n=101 participants at risk
Participants received 15 mg of suvorexant orally QD for 5 to 7 days.
|
Placebo
n=102 participants at risk
Participants received suvorexant-matching placebo orally QD for 5 to 7 days.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.99%
1/101 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/102 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/101 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.98%
1/102 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Infections and infestations
Pyelonephritis
|
0.99%
1/101 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/102 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Infections and infestations
Urosepsis
|
0.99%
1/101 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/102 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.99%
1/101 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.98%
1/102 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.99%
1/101 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/102 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/101 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.98%
1/102 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.99%
1/101 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/102 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/101 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.98%
1/102 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.00%
0/101 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.98%
1/102 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/101 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.98%
1/102 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.99%
1/101 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/102 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.99%
1/101 • Number of events 1 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
0.00%
0/102 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
Other adverse events
| Measure |
Suvorexant
n=101 participants at risk
Participants received 15 mg of suvorexant orally QD for 5 to 7 days.
|
Placebo
n=102 participants at risk
Participants received suvorexant-matching placebo orally QD for 5 to 7 days.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
22.8%
23/101 • Number of events 23 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
20.6%
21/102 • Number of events 21 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
8/101 • Number of events 8 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
11.8%
12/102 • Number of events 12 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
13/101 • Number of events 13 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
15.7%
16/102 • Number of events 16 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
General disorders
Pyrexia
|
4.0%
4/101 • Number of events 4 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
5.9%
6/102 • Number of events 6 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
7/101 • Number of events 7 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
2.9%
3/102 • Number of events 3 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.0%
5/101 • Number of events 5 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
8.8%
9/102 • Number of events 9 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.0%
5/101 • Number of events 5 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
5.9%
6/102 • Number of events 6 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Psychiatric disorders
Delirium
|
17.8%
18/101 • Number of events 19 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
28.4%
29/102 • Number of events 30 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
|
Psychiatric disorders
Insomnia
|
17.8%
18/101 • Number of events 18 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
17.6%
18/102 • Number of events 19 • Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER