Trial Outcomes & Findings for A Study of Seltorexant in Participants With Probable Alzheimer's Disease (NCT NCT05307692)
NCT ID: NCT05307692
Last Updated: 2025-04-27
Results Overview
The NPI-12, measure of psychobehavioral disturbances assessed frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain was rated on a 4-point scale (from 1=rarely to 4=very often) and severity on a 3-point scale (from 1=mild to 3=severe), with the score for each domain being product of frequency and severity scores, such that each domain was scored from 1 to 12. The NPI-12 total score was the sum of 12 domain scores, ranging from 0 (best) to 144 (worst), higher score represented greater frequency and worst severity of the symptoms. NPI-C was an instrument developed on basis of original NPI that gives a score based on product of frequency and severity ratings of 12 symptom domains that were summed to a total score. NPI-C domains: agitation and aggression NPI-C A+A were scored based on both caregiver and participant interviews and score ranged from 0 (does not occur) to 63 (severe). Higher scores indicated more severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Baseline (Day 1) and Day 43
Results posted on
2025-04-27
Participant Flow
Participant milestones
| Measure |
DB: Placebo
Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.
|
DB: Seltorexant
Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.
|
Follow-up (FU): Placebo
After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.
|
FU: Seltorexant
After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.
|
|---|---|---|---|---|
|
Double-blind (DB) Phase (Day 1- Day 43):
STARTED
|
44
|
44
|
0
|
0
|
|
Double-blind (DB) Phase (Day 1- Day 43):
Treated
|
42
|
43
|
0
|
0
|
|
Double-blind (DB) Phase (Day 1- Day 43):
COMPLETED
|
39
|
35
|
0
|
0
|
|
Double-blind (DB) Phase (Day 1- Day 43):
NOT COMPLETED
|
5
|
9
|
0
|
0
|
|
FU Phase (Day 43 to Day 57):
STARTED
|
0
|
0
|
39
|
38
|
|
FU Phase (Day 43 to Day 57):
COMPLETED
|
0
|
0
|
39
|
34
|
|
FU Phase (Day 43 to Day 57):
NOT COMPLETED
|
0
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
DB: Placebo
Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.
|
DB: Seltorexant
Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.
|
Follow-up (FU): Placebo
After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.
|
FU: Seltorexant
After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.
|
|---|---|---|---|---|
|
Double-blind (DB) Phase (Day 1- Day 43):
Adverse Event
|
0
|
1
|
0
|
0
|
|
Double-blind (DB) Phase (Day 1- Day 43):
Protocol-specified withdrawal criterion met
|
0
|
2
|
0
|
0
|
|
Double-blind (DB) Phase (Day 1- Day 43):
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Double-blind (DB) Phase (Day 1- Day 43):
Withdrawal by Subject
|
2
|
3
|
0
|
0
|
|
Double-blind (DB) Phase (Day 1- Day 43):
Other
|
0
|
1
|
0
|
0
|
|
Double-blind (DB) Phase (Day 1- Day 43):
Randomized but not treated
|
2
|
1
|
0
|
0
|
|
FU Phase (Day 43 to Day 57):
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
FU Phase (Day 43 to Day 57):
Protocol Violation
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Study of Seltorexant in Participants With Probable Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
DB: Placebo
n=42 Participants
Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.
|
DB: Seltorexant
n=43 Participants
Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.6 years
STANDARD_DEVIATION 7.75 • n=99 Participants
|
73.4 years
STANDARD_DEVIATION 6.18 • n=107 Participants
|
73 years
STANDARD_DEVIATION 6.97 • n=206 Participants
|
|
Age, Customized
Adults (18-64 years)
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Customized
From 65 to 84 years
|
35 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
UNITED STATES
|
42 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Age Categorical
Adults (18-64 years)
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age Categorical
From 65 to 84 years
|
35 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Age Categorical
85 years and over
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 43Population: Full analysis set (FAS) included all randomized participants who took at least 1 dose of study intervention. 'N' (number of participants analyzed): participants evaluable for this outcome measure. Estimand 1 used to analyze benefit from seltorexant 20 mg versus placebo in adults and elderly participants with probable Alzheimer's disease (AD) with clinically significant agitation/aggression who took study intervention as directed and regardless treatment discontinuation without treatment switch.
The NPI-12, measure of psychobehavioral disturbances assessed frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain was rated on a 4-point scale (from 1=rarely to 4=very often) and severity on a 3-point scale (from 1=mild to 3=severe), with the score for each domain being product of frequency and severity scores, such that each domain was scored from 1 to 12. The NPI-12 total score was the sum of 12 domain scores, ranging from 0 (best) to 144 (worst), higher score represented greater frequency and worst severity of the symptoms. NPI-C was an instrument developed on basis of original NPI that gives a score based on product of frequency and severity ratings of 12 symptom domains that were summed to a total score. NPI-C domains: agitation and aggression NPI-C A+A were scored based on both caregiver and participant interviews and score ranged from 0 (does not occur) to 63 (severe). Higher scores indicated more severity.
Outcome measures
| Measure |
DB: Placebo
n=37 Participants
Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.
|
DB: Seltorexant
n=36 Participants
Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.
|
|---|---|---|
|
Change From Baseline in Neuropsychiatric Inventory Clinician Version (NPI-C) Sum of Agitation and Aggression Domain Scores (NPI-C A+A) at Day 43: Analyzed Under Estimand 1
|
-9.6 Score on a scale
Standard Deviation 8.35
|
-13.4 Score on a scale
Standard Deviation 9.31
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 43Population: Full analysis set (FAS) included all randomized participants who took at least 1 dose of study intervention. 'N' (number of participants analyzed): participants evaluable for this outcome measure. Estimand 2 was used to analyze benefit from seltorexant 20 mg versus placebo in adults and elderly participants with probable AD with clinically significant agitation/aggression who took study intervention as directed and regardless of treatment discontinuation without treatment switch.
The NPI-12, measure of psychobehavioral disturbances assessed frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain was rated on a 4-point scale (from 1=rarely to 4=very often) and severity on a 3-point scale (from 1=mild to 3=severe), with the score for each domain being product of frequency and severity scores, such that each domain was scored from 1 to 12. The NPI-12 total score was the sum of 12 domain scores, ranging from 0 (best) to 144 (worst), higher score represented greater frequency and worst severity of the symptoms. NPI-C was an instrument developed on the basis of original NPI that gives a score based on product of frequency and severity ratings of 12 symptom domains that were summed to a total score. NPI-C domains: agitation and aggression NPI-C A+A were scored based on both caregiver and participant interviews and score ranged from 0 (does not occur) to 63 (severe). Higher scores indicated more severity.
Outcome measures
| Measure |
DB: Placebo
n=38 Participants
Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.
|
DB: Seltorexant
n=36 Participants
Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.
|
|---|---|---|
|
Change From Baseline in NPI-C A+A at Day 43: Analyzed Under Estimand 2
|
-9.6 Score on a scale
Standard Deviation 8.25
|
-13.4 Score on a scale
Standard Deviation 9.31
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 43Population: FAS included all randomized participants who took at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
The CMAI-C, 37-item scale, measured the ability of a drug to reduce overall frequency of agitation symptoms, including aggressive behaviors. Individual items were rated by the clinician on a scale of 1 (never) to 7 (several times per hour) in which higher score represented the most frequent for each item assessed. CMAI-C total score was a sum of all categories that ranged from 37 (never) to 259 (several times), where higher score indicated greater severity.
Outcome measures
| Measure |
DB: Placebo
n=38 Participants
Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.
|
DB: Seltorexant
n=36 Participants
Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.
|
|---|---|---|
|
Change From Baseline in Cohen-Mansfield Agitation Inventory- Community Version (CMAI-C) Total Score at Day 43
|
-17.5 Score on a scale
Standard Deviation 18.67
|
-20.3 Score on a scale
Standard Deviation 21.69
|
SECONDARY outcome
Timeframe: Baseline and Day 43Population: FAS included all randomized participants who took at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
SDI: based on caregiver (CG) interview and expanded version of item 11 (night-time behavioral disturbances) of NPI-12. It described frequency, severity and CG burden of sleep-disturbed behaviors for period prior to its administration. It consisted of 7 sub-questions from NPI-12 sleep disturbance item. Each sub-question was made into separate questions with frequency, severity, and CG distress rated with respect to participant. SDI score derived after CG rated frequency, severity of each of 7 separate sleep disturbance symptoms. CG distress ratings were not part of SDI total score, but distress was measured. Frequency scored on scale of 0 (not present) to 4 (once or more per day), severity scored on scale of 0 (not present) to 3 (occurrence of nighttime behaviors) and CG distress rated on scale of 0 (not at all) to 5 (extremely). SDI average total score=average frequency of item 1 to 7 multiplied with average severity of items 1 to 7; ranged from 0 to 12; higher score=greater severity.
Outcome measures
| Measure |
DB: Placebo
n=36 Participants
Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.
|
DB: Seltorexant
n=36 Participants
Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.
|
|---|---|---|
|
Change From Baseline in Sleep Disorder Inventory (SDI) Average Total Score at Day 43
|
-0.8 Score on a scale
Standard Deviation 1.02
|
-0.5 Score on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Either Day 15 (8 and 14 hours post dose on night of Day 14) or Day 43 (8 and 14 hours post dose on night of Day 42)Population: The PK analysis set included all randomized participants to the seltorexant treatment group and with at least one PK sample taken. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
The pharmacokinetic (PK) sample collection was done based on the availability of the participants either on Day 15 or 43 and thus collected data were analyzed and summary data were reported in this outcome measure. Plasma samples were analyzed using liquid chromatography/mass spectrometry/mass spectrometry (LC-MS/MS) method.
Outcome measures
| Measure |
DB: Placebo
n=22 Participants
Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.
|
DB: Seltorexant
Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.
|
|---|---|---|
|
Observed Plasma Concentrations of Seltorexant and Its Metabolite (M12)
Total Seltorexant
|
121 nanograms per milliliter (ng/mL)
Standard Deviation 156
|
—
|
|
Observed Plasma Concentrations of Seltorexant and Its Metabolite (M12)
Total M12
|
141 nanograms per milliliter (ng/mL)
Standard Deviation 164
|
—
|
Adverse Events
DB: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DB: Seltorexant
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Follow-up (FU): Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FU: Seltorexant
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB: Placebo
n=42 participants at risk
Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.
|
DB: Seltorexant
n=43 participants at risk
Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.
|
Follow-up (FU): Placebo
n=39 participants at risk
After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.
|
FU: Seltorexant
n=38 participants at risk
After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neuroendocrine Tumour
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.6%
1/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.3%
1/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
Other adverse events
| Measure |
DB: Placebo
n=42 participants at risk
Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.
|
DB: Seltorexant
n=43 participants at risk
Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.
|
Follow-up (FU): Placebo
n=39 participants at risk
After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.
|
FU: Seltorexant
n=38 participants at risk
After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.3%
1/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.3%
1/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Malignant Biliary Obstruction
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.6%
1/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.3%
1/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.3%
1/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Infections and infestations
Orchitis
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.6%
1/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
1/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Injury
|
2.4%
1/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.6%
1/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.6%
1/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.3%
1/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Psychiatric disorders
Confusional Arousal
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.3%
1/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.3%
1/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/42 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/43 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
0.00%
0/39 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
2.6%
1/38 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57
All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER