Trial Outcomes & Findings for Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022) (NCT NCT01554176)

Results Overview

The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with total scores ranging from 0 to 60; higher scores correspond to greater symptom severity. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

Baseline and Week 6

Results posted on

2018-11-07

Participant Flow

One participant in the Filorexant 10 mg (Treatment Phase) arm did not receive study drug and was discontinued from the study; the reason given for discontinuation is given as "non-compliance with study drug".

During the 1-2 week screening period participants will be evaluated to determine if they meet study entry criteria. The screening period will serve as a wash-out period for participants taking prohibited medications.

Participant milestones

Participant milestones
Measure	Filorexant 10 mg (Treatment Phase) Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.	Filorexant 10 mg/Placebo (Run-out Phase) Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.	Placebo/Placebo (Run-out Phase) Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Treatment Phase STARTED	65	64	0	0	0
Treatment Phase Treated	64	64	0	0	0
Treatment Phase COMPLETED	57	59	0	0	0
Treatment Phase NOT COMPLETED	8	5	0	0	0
Run-out Phase STARTED	0	0	29	28	59
Run-out Phase Treated	0	0	29	28	59
Run-out Phase COMPLETED	0	0	29	27	59
Run-out Phase NOT COMPLETED	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Filorexant 10 mg (Treatment Phase) Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Filorexant 10 mg/Placebo (Run-out Phase) Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
Treatment Phase Protocol Violation	1	2	0
Treatment Phase Physician Decision	1	1	0
Treatment Phase Lack of Efficacy	0	1	0
Treatment Phase Adverse event, non-fatal	1	1	0
Treatment Phase Non-compliance with study drug	1	0	0
Treatment Phase Withdrawal by Subject	1	0	0
Treatment Phase Lost to Follow-up	3	0	0
Run-out Phase Protocol Violation	0	0	1

Baseline Characteristics

Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Filorexant 10 mg (Treatment Phase) n=65 Participants Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=64 Participants Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Total n=129 Participants Total of all reporting groups
Age, Continuous	47.8 Years STANDARD_DEVIATION 12.4 • n=5 Participants	50.0 Years STANDARD_DEVIATION 10.3 • n=7 Participants	48.9 Years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6

Population: Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 value.

The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with total scores ranging from 0 to 60; higher scores correspond to greater symptom severity. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.

Outcome measures

Outcome measures
Measure	Filorexant 10 mg (Treatment Phase) n=58 Participants Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=61 Participants Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Placebo/Placebo (Run-out Phase) Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score Baseline	30.3 score on a scale Standard Deviation 4.6	31 score on a scale Standard Deviation 4.3	—
Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score Change at Week 6	-11 score on a scale Standard Deviation 9.5	-10.3 score on a scale Standard Deviation 8.2	—

PRIMARY outcome

Timeframe: Up to Week 6

Population: All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.

An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the treatment phase (up to study Week 6) are counted once in this summary.

Outcome measures

Outcome measures
Measure	Filorexant 10 mg (Treatment Phase) n=64 Participants Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=64 Participants Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Placebo/Placebo (Run-out Phase) Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Number of Participants With an Adverse Event (AE) During Treatment Phase	27 Participants	17 Participants	—

PRIMARY outcome

Timeframe: Up to Week 6

Population: All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.

An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the treatment phase (up to study Week 6) are counted once in this summary.

Outcome measures

Outcome measures
Measure	Filorexant 10 mg (Treatment Phase) n=64 Participants Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=64 Participants Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Placebo/Placebo (Run-out Phase) Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Phase	1 Participants	1 Participants	—

PRIMARY outcome

Timeframe: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks)

Population: All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.

An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the 2-week run-out phase and/or during the 2-week follow up after the last dose of study drug, are counted once in this summary.

Outcome measures

Outcome measures
Measure	Filorexant 10 mg (Treatment Phase) n=29 Participants Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=28 Participants Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Placebo/Placebo (Run-out Phase) n=59 Participants Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Number of Participants With an AE During Run-out Phase	6 Participants	3 Participants	9 Participants

PRIMARY outcome

Timeframe: From first run-out dose (following Week 6 visit) up to Week 8 (2 weeks)

Population: All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.

An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) or a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the 2-week run-out phase are counted once in this summary.

Outcome measures

Outcome measures
Measure	Filorexant 10 mg (Treatment Phase) n=29 Participants Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=28 Participants Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Placebo/Placebo (Run-out Phase) n=59 Participants Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Number of Participants Who Discontinued Study Drug Due to an AE During Run-out Phase	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 MADRS score.

The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with higher scores indicating greater symptom severity. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity. This measure considered 9 of the 10 MADRS items: apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. It excluded "reduced sleep." The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.

Outcome measures

Outcome measures
Measure	Filorexant 10 mg (Treatment Phase) n=58 Participants Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=61 Participants Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Placebo/Placebo (Run-out Phase) Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Change From Baseline to Week 6 in MADRS Total Score Excluding the Sleep Item Baseline	26.5 score on a scale Standard Deviation 4.1	27.2 score on a scale Standard Deviation 4.1	—
Change From Baseline to Week 6 in MADRS Total Score Excluding the Sleep Item Change at Week 6	-9.5 score on a scale Standard Deviation 8.5	-9.1 score on a scale Standard Deviation 7.4	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 Beck Subscale score.

The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). The Bech subscale of the HAM-D17 is composed of 6 identified items out of the 17 items rated. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). Total score ranged from 0 to 22, with a higher score indicating greater symptom severity. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). The reported measure is the change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.

Outcome measures

Outcome measures
Measure	Filorexant 10 mg (Treatment Phase) n=56 Participants Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=61 Participants Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Placebo/Placebo (Run-out Phase) Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Change From Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item Version (HAM-D17) Bech Subscale Score Baseline	13.1 score on a scale Standard Deviation 2.4	13.0 score on a scale Standard Deviation 2.1	—
Change From Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item Version (HAM-D17) Bech Subscale Score Change at Week 6	-4.7 score on a scale Standard Deviation 4.8	-4.2 score on a scale Standard Deviation 4.0	—

SECONDARY outcome

Timeframe: Week 6

Population: Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 score.

The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4), with higher scores indicating greater symptom severity. Total score ranged from 0 to 54. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. A participant with HAM-D17 total score ≤7 at Week 6 of the Treatment Phase was defined to have achieved HAM-D17 remission.

Outcome measures

Outcome measures
Measure	Filorexant 10 mg (Treatment Phase) n=56 Participants Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=61 Participants Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Placebo/Placebo (Run-out Phase) Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Percentage of Participants With HAM-D17 Remission (HAM-D17 Total Score ≤7) at Week 6	21.4 percentage of participants	9.8 percentage of participants	—

Adverse Events

Filorexant 10 mg (Treatment Phase)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo (Treatment Phase)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Filorexant 10 mg/Placebo (Run-out Phase)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo/Placebo (Run-out Phase)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Filorexant 10 mg (Treatment Phase) n=64 participants at risk Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=64 participants at risk Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) n=29 participants at risk Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.	Filorexant 10 mg/Placebo (Run-out Phase) n=28 participants at risk Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.	Placebo/Placebo (Run-out Phase) n=59 participants at risk Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the treatment phase.
Nervous system disorders Presyncope	0.00% 0/64 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/64 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/29 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/28 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	1.7% 1/59 • Number of events 1 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.
Infections and infestations Diverticulitis	1.6% 1/64 • Number of events 1 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/64 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/29 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/28 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/59 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.

Other adverse events

Other adverse events
Measure	Filorexant 10 mg (Treatment Phase) n=64 participants at risk Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.	Placebo (Treatment Phase) n=64 participants at risk Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.	Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) n=29 participants at risk Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.	Filorexant 10 mg/Placebo (Run-out Phase) n=28 participants at risk Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.	Placebo/Placebo (Run-out Phase) n=59 participants at risk Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the treatment phase.
Psychiatric disorders Suicidal ideation	7.8% 5/64 • Number of events 5 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	1.6% 1/64 • Number of events 1 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	10.3% 3/29 • Number of events 3 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	3.6% 1/28 • Number of events 1 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	1.7% 1/59 • Number of events 1 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/64 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	6.2% 4/64 • Number of events 4 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/29 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/28 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/59 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.
Nervous system disorders Headache	6.2% 4/64 • Number of events 5 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	7.8% 5/64 • Number of events 6 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/29 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/28 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/59 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.
Nervous system disorders Somnolence	7.8% 5/64 • Number of events 5 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/64 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/29 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/28 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.	0.00% 0/59 • Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks) All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER