Insomnia
Conditions
Brief summary
Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects. Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects with primary insomnia following single oral dosing of E2006 in the evening approximately 30 minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.
Interventions
DRUGE2006 1.0 mg
E2006 1.0 mg capsule.
DRUGE2006 2.5 mg
E2006 2.5 mg capsule.
DRUGE2006 5.0 mg
E2006 5.0 mg (2 capsules of 2.5 mg each).
DRUGE2006 10.0 mg
E2006 10.0 mg capsule.
DRUGE2006 25.0 mg
E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).
DRUGE2006 50.0 mg
E2006 50.0 mg capsule.
DRUGE2006 100 mg
E2006 100 mg (2 capsules of 50 mg each).
DRUGE2006 200 mg
E2006 200 mg (4 capsules of 50 mg each).
DRUGZolpidem 10 mg
Zolpidem 10 mg immediate release tablet.
DRUGE2006 Matched Placebo or Zolpidem Matched Placebo
E2006-matched placebo capsules or zolpidem-matched placebo tablets.
DRUGE2006 Matched Placebo
E2006-matched placebo capsule.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: Healthy Subjects: * With habitual time in bed \> 7 hours, with lights out 2200 to 2400 and lights on 0600 to 0800 * Who report typical sleep latency of \</= 30 minutes * With typical total sleep time (TST) \>/= 420 minutes Primary Insomnia Subjects: * Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision \[DSM-IV-TR\]) present at the time of Screening for at least 3 months * With a score of \> 15 on the Insomnia Severity Index (ISI) at Screening * Who report taking \>/= 30 minutes to fall asleep on at least 3 nights per week for the past month * Who report 6.5 hours sleep or less on at least 3 nights per week for the past month * With mean latency to persistent sleep (LPS) on both baseline nights of \>/= 20 minutes with neither night \< 15 minutes * With mean wake after sleep onset (WASO) \>/= 20 minutes on both baseline nights, with neither night \< 15 minutes or mean TST \> 420 minutes Key
Exclusion criteria
* With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg syndrome \[RLS\], narcolepsy, or circadian rhythm disorder) other than primary insomnia (for Part B) * Subjects with any clinically abnormal symptom or organ impairment found in medical history, symptoms/signs, vital signs, ECG finding, or laboratory test results which require medical treatment * All females must be of non-childbearing potential * With a known history of significant neurological or serious psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Baseline up to Day 11 | — |
| Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | Baseline up to Day 6 | — |
| Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | Baseline up to Day 11 | — |
| Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | Baseline up to Day 11 | — |
| Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, Day 11 | The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is yes for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is yes for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of Participants with any suicidality has been reported for this outcome measure. |
| Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Baseline, Day 1 | LPS was the duration of time in minutes from lights off to the first 30 seconds of recording (epoch) of 20 consecutive epochs of non-wakefulness as measured by PSG. |
| Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Baseline, Day 1 | TST was the duration in minutes including rapid eye movement (REM) sleep plus non-rapid eye movement (NREM) sleep during the time spent in bed. |
| Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Baseline, Day 1 | Sleep efficiency was defined as the TST divided by the time in bed (minutes) multiplied by 100. TST was the duration in minutes including REM sleep plus NREM sleep during the time spent in bed. |
| Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Baseline, Day 1 | WASO was defined as the duration (in minutes) of wakefulness from onset of persistent sleep to lights-on. |
| Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Baseline, Day 1 | Number of awakenings was determined from LPS to lights-on. LPS was the duration of time measured from lights off to the first 30 seconds of PSG measurement recording (epoch) of 20 consecutive epochs of non-wake. An awakening was defined as a PSG recording of at least two consecutive wake epochs. |
| Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Baseline, Day 1 | Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs. |
| Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1, Day 6 | Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Rate quality of your sleep has been reported. |
| Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Baseline, Day 1 | Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs. |
| Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Baseline, Day 1 | Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs. |
| Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1, Day 6 | Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question How long did you sleep last night has been reported. |
| Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1, Day 6 | Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Time to fall asleep last night has been reported. |
| Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose), Day 6 | DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function. |
| Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1, Day 6 | Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Number of awakening after falling asleep has been reported. |
| Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1, Day 6 | Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Time spent awake after falling asleep has been reported. |
| Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose), Day 6 | PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment. |
| Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Day 1 (Pre-dose), Day 6 | KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 9, which indicates extremely sleepy, can't stay awake. Higher numbers indicating sleepier and lower numbers more alert. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values | Baseline up to Day 11 | — |
| Part A: Maximum Plasma Concentration (Cmax) of E2006 | Day 1: Pre-dose, up to 240 hours post-dose | — |
| Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, Day 11 | The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess any suicidality, any suicidal Behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is yes for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious, behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is yes for any of these questions-wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of participants with any suicidality has been reported for this outcome measure. |
| Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 | Day 1: Pre-dose, up to 240 hours post-dose | — |
| Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 | Day 1: Pre-dose, up to 240 hours post-dose | — |
| Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 | Day 1: Pre-dose, up to 240 hours post-dose | — |
| Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 | Day 1: Pre-dose, up to 240 hours post-dose | — |
| Part A: Terminal Half-life (t1/2) of E2006 in Plasma | Day 1: Pre-dose, up to 240 hours post-dose | — |
| Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) | Day 1: Pre-dose, up to 240 hours post-dose | — |
| Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) | Day 1: Pre-dose, up to 240 hours post-dose | — |
| Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) | Day 1: Pre-dose, up to 120 hours post-dose | — |
| Part A: Renal Clearance (CLR) of Drug E2006 | Day 1: Pre-dose, up to 120 hours post-dose | — |
| Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose), up to Day 6 | DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function. In this outcome measure, data for participants who received placebo matched to 1 mg, 2.5 mg, 5 mg E2006 and matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006, has been presented separately. |
| Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose), Day 6 | PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment. In this outcome measure, data for participants who received placebo matched to 1 mg, 2.5 mg, 5 mg E2006 and matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006, has been presented separately. |
| Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose), Day 6 | KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 9, which indicates extremely sleepy, can't stay awake. Higher numbers indicating sleepier and lower numbers more alert. In this outcome measure, data for participants who received placebo matched to 1 mg, 2.5 mg, 5 mg E2006 and matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006, has been presented separately. |
| Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1, Day 6 | Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question How long did you sleep last night has been reported. |
| Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1, Day 6 | Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Time to fall asleep last night has been reported. |
| Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1, Day 6 | Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Number of awakening after falling asleep has been reported. |
| Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1, Day 6 | Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Time spent awake after falling asleep has been reported. |
| Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1, Day 6 | Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Rate quality of your sleep has been reported. |
| Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | Baseline up to Day 11 | — |
| Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values | Baseline up to Day 6 | — |
| Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values | Baseline up to Day 11 | — |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 2 investigative sites in United States from 05 October 2011 to 11 August 2012.
Pre-assignment details
Part A: A total of 160 healthy participants were screened, of which 96 were screen failures and 64 were enrolled and randomized to receive study treatment. Part B: A total of 281 otherwise healthy participants with primary insomnia were screened, of which 223 were screen failures and 58 were enrolled and randomized to receive study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Part A: E2006 Matched Placebo Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | 16 |
| Part A: E2006 1.0 mg Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | 6 |
| Part A: E2006 2.5 mg Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | 6 |
| Part A: E2006 5 mg Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. | 6 |
| Part A: E2006 10 mg Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | 6 |
| Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. | 6 |
| Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | 6 |
| Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. | 6 |
| Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. | 6 |
| Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. | 12 |
| Part B: Zolpidem 10 mg Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. | 11 |
| Part B: E2006 2.5 mg Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. | 13 |
| Part B: E2006 10 mg Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. | 10 |
| Part B: E2006 25 mg Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. | 12 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A (11 Days) | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A (11 Days) | Participant Choice | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part B (11 Days) | Participant Choice | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part A: E2006 1.0 mg | Part A: E2006 2.5 mg | Part A: E2006 5 mg | Part A: E2006 Matched Placebo | Part A: E2006 10 mg | Part A: E2006 25 mg | Part A: E2006 50 mg | Part A: E2006 100 mg | Part A: E2006 200 mg | Part B: E2006 Matched Placebo or Zolpidem Matched Placebo | Part B: Zolpidem 10 mg | Part B: E2006 2.5 mg | Part B: E2006 10 mg | Part B: E2006 25 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 122 Participants | 6 Participants | 6 Participants | 6 Participants | 16 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants | 11 Participants | 13 Participants | 10 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 104 Participants | 4 Participants | 5 Participants | 4 Participants | 14 Participants | 5 Participants | 5 Participants | 4 Participants | 3 Participants | 3 Participants | 12 Participants | 11 Participants | 12 Participants | 10 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 3 Participants | 2 Participants | 3 Participants | 6 Participants | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 6 Participants | 2 Participants | 7 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 62 Participants | 3 Participants | 3 Participants | 3 Participants | 8 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants | 6 Participants | 8 Participants | 6 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Female | 59 Participants | 3 Participants | 3 Participants | 3 Participants | 8 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 5 Participants | 6 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 63 Participants | 3 Participants | 3 Participants | 3 Participants | 8 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 6 Participants | 7 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 11 | 0 / 13 | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 7 / 16 | 1 / 6 | 0 / 6 | 1 / 6 | 4 / 6 | 2 / 6 | 4 / 6 | 2 / 6 | 5 / 6 | 1 / 12 | 6 / 11 | 2 / 13 | 6 / 10 | 6 / 12 |
| serious Total, serious adverse events | 0 / 16 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 11 | 0 / 13 | 0 / 10 | 0 / 12 |
Outcome results
Primary
Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is yes for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is yes for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of Participants with any suicidality has been reported for this outcome measure.
Time frame: Baseline, Day 11
Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 Matched Placebo | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 1.0 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 1.0 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 2.5 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 2.5 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 5 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 5 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 10 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 10 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 25 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 25 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 50 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 50 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 100 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 100 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 200 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 200 mg | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
Primary
Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values
Time frame: Baseline up to Day 11
Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | 0 Participants |
| Part A: E2006 1.0 mg | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | 0 Participants |
| Part A: E2006 2.5 mg | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | 0 Participants |
| Part A: E2006 5 mg | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | 0 Participants |
| Part A: E2006 10 mg | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | 0 Participants |
| Part A: E2006 25 mg | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | 0 Participants |
| Part A: E2006 50 mg | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | 0 Participants |
| Part A: E2006 100 mg | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | 0 Participants |
| Part A: E2006 200 mg | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | 0 Participants |
Primary
Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values
Time frame: Baseline up to Day 6
Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 6 Participants |
| Part A: E2006 1.0 mg | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 1 Participants |
| Part A: E2006 2.5 mg | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 3 Participants |
| Part A: E2006 5 mg | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 1 Participants |
| Part A: E2006 10 mg | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 2 Participants |
| Part A: E2006 25 mg | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 2 Participants |
| Part A: E2006 50 mg | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 3 Participants |
| Part A: E2006 100 mg | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 1 Participants |
| Part A: E2006 200 mg | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 0 Participants |
Primary
Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values
Time frame: Baseline up to Day 11
Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 1.0 mg | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 2.5 mg | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 5 mg | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 10 mg | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 25 mg | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 50 mg | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 100 mg | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 200 mg | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
Primary
Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 11
Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 7 Participants |
| Part A: E2006 Matched Placebo | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 1.0 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 1.0 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 1 Participants |
| Part A: E2006 2.5 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 0 Participants |
| Part A: E2006 2.5 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 5 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 1 Participants |
| Part A: E2006 5 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 10 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 4 Participants |
| Part A: E2006 10 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 25 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 2 Participants |
| Part A: E2006 25 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 50 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 4 Participants |
| Part A: E2006 50 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 100 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 2 Participants |
| Part A: E2006 100 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 200 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 200 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 5 Participants |
Primary
Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1
Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.
Time frame: Baseline, Day 1
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N1: Baseline | 37.8 minutes | Standard Deviation 16.6 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N1: Change at Day 1 | 2.38 minutes | Standard Deviation 17.8 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N2: Baseline | 190 minutes | Standard Deviation 39.4 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N2: Change at Day 1 | 10.4 minutes | Standard Deviation 34.3 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Baseline | 47.7 minutes | Standard Deviation 33.2 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Change at Day 1 | 1.94 minutes | Standard Deviation 12.7 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage REM: Baseline | 59.4 minutes | Standard Deviation 19.3 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage REM: Change at Day 1 | -0.729 minutes | Standard Deviation 13.3 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N2: Baseline | 195 minutes | Standard Deviation 27.7 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Change at Day 1 | 16.3 minutes | Standard Deviation 17.4 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N1: Baseline | 35.1 minutes | Standard Deviation 11.3 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N2: Change at Day 1 | 34.4 minutes | Standard Deviation 33.9 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N1: Change at Day 1 | 3.41 minutes | Standard Deviation 17.4 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage REM: Change at Day 1 | 7.14 minutes | Standard Deviation 19.2 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Baseline | 53.4 minutes | Standard Deviation 35.2 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage REM: Baseline | 65.3 minutes | Standard Deviation 20 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage REM: Baseline | 56.7 minutes | Standard Deviation 15.7 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage REM: Change at Day 1 | 26.3 minutes | Standard Deviation 31.8 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N2: Change at Day 1 | 29.6 minutes | Standard Deviation 52.3 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Change at Day 1 | 3.73 minutes | Standard Deviation 18.3 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N2: Baseline | 198 minutes | Standard Deviation 52.7 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N1: Change at Day 1 | -7.65 minutes | Standard Deviation 15 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N1: Baseline | 50.1 minutes | Standard Deviation 15.5 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Baseline | 36.5 minutes | Standard Deviation 32.1 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N1: Change at Day 1 | 14.7 minutes | Standard Deviation 19.9 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N2: Baseline | 212 minutes | Standard Deviation 63.6 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N2: Change at Day 1 | 21.5 minutes | Standard Deviation 38.8 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Baseline | 38.3 minutes | Standard Deviation 37.8 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Change at Day 1 | 14.9 minutes | Standard Deviation 28.8 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage REM: Change at Day 1 | 10.7 minutes | Standard Deviation 29.5 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N1: Baseline | 40.7 minutes | Standard Deviation 17.3 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage REM: Baseline | 54.0 minutes | Standard Deviation 14 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N2: Change at Day 1 | 33.6 minutes | Standard Deviation 36.6 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage REM: Change at Day 1 | 40.8 minutes | Standard Deviation 21.7 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N2: Baseline | 175 minutes | Standard Deviation 29.2 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage REM: Baseline | 68.8 minutes | Standard Deviation 19.6 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N1: Baseline | 38.9 minutes | Standard Deviation 11 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Change at Day 1 | 12.7 minutes | Standard Deviation 11.3 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N1: Change at Day 1 | -1.35 minutes | Standard Deviation 11.1 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Baseline | 59.1 minutes | Standard Deviation 18.2 |
Primary
Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1
LPS was the duration of time in minutes from lights off to the first 30 seconds of recording (epoch) of 20 consecutive epochs of non-wakefulness as measured by PSG.
Time frame: Baseline, Day 1
Population: Pharmacodynamic (PD) analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Baseline | 56.3 minutes | Standard Deviation 20.5 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Change From Baseline at Day 1 | -7.17 minutes | Standard Deviation 30.9 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Baseline | 51.8 minutes | Standard Deviation 26.7 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Change From Baseline at Day 1 | -33.1 minutes | Standard Deviation 20.3 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Baseline | 50.1 minutes | Standard Deviation 35.1 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Change From Baseline at Day 1 | -28.1 minutes | Standard Deviation 45.2 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Change From Baseline at Day 1 | -28.8 minutes | Standard Deviation 39 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Baseline | 55.9 minutes | Standard Deviation 40.5 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Baseline | 62.8 minutes | Standard Deviation 38.3 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | Change From Baseline at Day 1 | -43.9 minutes | Standard Deviation 35.9 |
Primary
Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1
Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.
Time frame: Baseline, Day 1
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Baseline | 167 stage shift | Standard Deviation 22.3 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 0.250 stage shift | Standard Deviation 35.7 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 4.18 stage shift | Standard Deviation 41.2 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Baseline | 168 stage shift | Standard Deviation 35.5 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Baseline | 174 stage shift | Standard Deviation 42.2 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | -16.3 stage shift | Standard Deviation 30.4 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Baseline | 188 stage shift | Standard Deviation 45.6 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 14.4 stage shift | Standard Deviation 53.1 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 14.0 stage shift | Standard Deviation 28.1 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | Baseline | 153 stage shift | Standard Deviation 36.7 |
Primary
Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1
Number of awakenings was determined from LPS to lights-on. LPS was the duration of time measured from lights off to the first 30 seconds of PSG measurement recording (epoch) of 20 consecutive epochs of non-wake. An awakening was defined as a PSG recording of at least two consecutive wake epochs.
Time frame: Baseline, Day 1
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Baseline | 10.5 awakenings | Standard Deviation 3.91 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 0.125 awakenings | Standard Deviation 3.48 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Baseline | 12.4 awakenings | Standard Deviation 5.33 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | -3.45 awakenings | Standard Deviation 3.08 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Baseline | 11.9 awakenings | Standard Deviation 3.48 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | -1.38 awakenings | Standard Deviation 4.87 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | -0.30 awakenings | Standard Deviation 6.85 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Baseline | 12.3 awakenings | Standard Deviation 4.08 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Baseline | 10.9 awakenings | Standard Deviation 3.52 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 0.542 awakenings | Standard Deviation 4.17 |
Primary
Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1
Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.
Time frame: Baseline, Day 1
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N1: Baseline | 11.8 percentage of sleep stage duration | Standard Deviation 5.74 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N1: Change at Day 1 | 0.00429 percentage of sleep stage duration | Standard Deviation 5.29 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N2: Baseline | 56.5 percentage of sleep stage duration | Standard Deviation 7.73 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N2: Change at Day 1 | 0.390 percentage of sleep stage duration | Standard Deviation 4.64 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Baseline | 14.0 percentage of sleep stage duration | Standard Deviation 8.74 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep : Change at Day 1 | 0.0613 percentage of sleep stage duration | Standard Deviation 2.9 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage REM: Baseline | 17.7 percentage of sleep stage duration | Standard Deviation 4.86 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage REM: Change at Day 1 | -0.455 percentage of sleep stage duration | Standard Deviation 3.58 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N2: Baseline | 56.3 percentage of sleep stage duration | Standard Deviation 6.7 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep : Change at Day 1 | 2.15 percentage of sleep stage duration | Standard Deviation 3.77 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N1: Baseline | 10.3 percentage of sleep stage duration | Standard Deviation 3.47 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N2: Change at Day 1 | -0.316 percentage of sleep stage duration | Standard Deviation 4.96 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N1: Change at Day 1 | -0.715 percentage of sleep stage duration | Standard Deviation 5.02 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage REM: Change at Day 1 | -1.12 percentage of sleep stage duration | Standard Deviation 4.13 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Baseline | 15.0 percentage of sleep stage duration | Standard Deviation 9.77 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage REM: Baseline | 18.4 percentage of sleep stage duration | Standard Deviation 4.59 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage REM: Baseline | 16.4 percentage of sleep stage duration | Standard Deviation 3.52 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage REM: Change at Day 1 | 4.67 percentage of sleep stage duration | Standard Deviation 6.54 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N2: Change at Day 1 | -0.306 percentage of sleep stage duration | Standard Deviation 7.49 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep : Change at Day 1 | -0.0852 percentage of sleep stage duration | Standard Deviation 6.1 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N2: Baseline | 57.5 percentage of sleep stage duration | Standard Deviation 10.9 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N1: Change at Day 1 | -4.28 percentage of sleep stage duration | Standard Deviation 6.11 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N1: Baseline | 15.2 percentage of sleep stage duration | Standard Deviation 5.7 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Baseline | 10.9 percentage of sleep stage duration | Standard Deviation 9.78 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N1: Change at Day 1 | 2.19 percentage of sleep stage duration | Standard Deviation 4.92 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N2: Baseline | 60.6 percentage of sleep stage duration | Standard Deviation 12 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N2: Change at Day 1 | -3.12 percentage of sleep stage duration | Standard Deviation 9.36 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Baseline | 11.8 percentage of sleep stage duration | Standard Deviation 12.1 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep : Change at Day 1 | 1.01 percentage of sleep stage duration | Standard Deviation 8.55 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage REM: Change at Day 1 | -0.0712 percentage of sleep stage duration | Standard Deviation 7.07 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N1: Baseline | 11.9 percentage of sleep stage duration | Standard Deviation 4.44 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage REM: Baseline | 15.7 percentage of sleep stage duration | Standard Deviation 3.46 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N2: Change at Day 1 | -2.73 percentage of sleep stage duration | Standard Deviation 5.77 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage REM: Change at Day 1 | 5.82 percentage of sleep stage duration | Standard Deviation 5.27 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N2: Baseline | 51.5 percentage of sleep stage duration | Standard Deviation 6.61 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage REM: Baseline | 19.8 percentage of sleep stage duration | Standard Deviation 4.93 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N1: Baseline | 11.5 percentage of sleep stage duration | Standard Deviation 2.54 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep : Change at Day 1 | -0.42 percentage of sleep stage duration | Standard Deviation 3.28 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N1: Change at Day 1 | -2.67 percentage of sleep stage duration | Standard Deviation 2.49 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | Stage N3/Slow Wave Sleep: Baseline | 17.2 percentage of sleep stage duration | Standard Deviation 4.75 |
Primary
Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1
Sleep efficiency was defined as the TST divided by the time in bed (minutes) multiplied by 100. TST was the duration in minutes including REM sleep plus NREM sleep during the time spent in bed.
Time frame: Baseline, Day 1
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Baseline | 69.8 percentage of time asleep | Standard Deviation 11.7 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 2.90 percentage of time asleep | Standard Deviation 9.93 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Baseline | 72.7 percentage of time asleep | Standard Deviation 10.4 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 12.8 percentage of time asleep | Standard Deviation 8.73 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Baseline | 71.1 percentage of time asleep | Standard Deviation 9.72 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 10.8 percentage of time asleep | Standard Deviation 12.6 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 12.9 percentage of time asleep | Standard Deviation 7.08 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Baseline | 71.9 percentage of time asleep | Standard Deviation 12.6 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Baseline | 71.3 percentage of time asleep | Standard Deviation 9.77 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 17.9 percentage of time asleep | Standard Deviation 10.4 |
Primary
Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1
TST was the duration in minutes including rapid eye movement (REM) sleep plus non-rapid eye movement (NREM) sleep during the time spent in bed.
Time frame: Baseline, Day 1
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Baseline | 335 minutes | Standard Deviation 56.2 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 14.0 minutes | Standard Deviation 47.6 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Baseline | 349 minutes | Standard Deviation 49.9 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 61.3 minutes | Standard Deviation 41.9 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Baseline | 341 minutes | Standard Deviation 46.7 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 51.9 minutes | Standard Deviation 60.5 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 61.8 minutes | Standard Deviation 34 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Baseline | 345 minutes | Standard Deviation 60.7 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Baseline | 342 minutes | Standard Deviation 46.9 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | 85.8 minutes | Standard Deviation 49.9 |
Primary
Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1
WASO was defined as the duration (in minutes) of wakefulness from onset of persistent sleep to lights-on.
Time frame: Baseline, Day 1
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Baseline | 95.7 minutes | Standard Deviation 52.9 |
| Part A: E2006 Matched Placebo | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | -7.52 minutes | Standard Deviation 27.3 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Baseline | 85.7 minutes | Standard Deviation 39.6 |
| Part A: E2006 1.0 mg | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | -32.1 minutes | Standard Deviation 30.7 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Baseline | 95.6 minutes | Standard Deviation 41.5 |
| Part A: E2006 2.5 mg | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | -28.9 minutes | Standard Deviation 59 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | -28.3 minutes | Standard Deviation 53.6 |
| Part A: E2006 5 mg | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Baseline | 84.7 minutes | Standard Deviation 64 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Baseline | 85.4 minutes | Standard Deviation 20.7 |
| Part A: E2006 10 mg | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | Change From Baseline at Day 1 | -45.6 minutes | Standard Deviation 21.1 |
Primary
Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6
Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question How long did you sleep last night has been reported.
Time frame: Day 1, Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 302.1 minutes | Standard Deviation 82.39 |
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | -3.3 minutes | Standard Deviation 74.66 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 292.3 minutes | Standard Deviation 61.21 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | 12.7 minutes | Standard Deviation 55.11 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 298.8 minutes | Standard Deviation 106.45 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | 42.4 minutes | Standard Deviation 89.08 |
| Part A: E2006 5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | -41.5 minutes | Standard Deviation 87.24 |
| Part A: E2006 5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 302.5 minutes | Standard Deviation 71.7 |
| Part A: E2006 10 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 276.3 minutes | Standard Deviation 82.77 |
| Part A: E2006 10 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | 20.0 minutes | Standard Deviation 60.11 |
Primary
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6
Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Number of awakening after falling asleep has been reported.
Time frame: Day 1, Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 2.7 number of awakenings | Standard Deviation 1.3 |
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -0.1 number of awakenings | Standard Deviation 1.16 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 2.7 number of awakenings | Standard Deviation 1.42 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -0.3 number of awakenings | Standard Deviation 1.1 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 2.8 number of awakenings | Standard Deviation 1.3 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -0.6 number of awakenings | Standard Deviation 1.39 |
| Part A: E2006 5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | 0.7 number of awakenings | Standard Deviation 2.31 |
| Part A: E2006 5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 2.7 number of awakenings | Standard Deviation 1.42 |
| Part A: E2006 10 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 3.6 number of awakenings | Standard Deviation 1.24 |
| Part A: E2006 10 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | 0.3 number of awakenings | Standard Deviation 0.97 |
Primary
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6
Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Rate quality of your sleep has been reported.
Time frame: Day 1, Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 2.8 score on a scale | Standard Deviation 0.72 |
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | -0.6 score on a scale | Standard Deviation 0.67 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 3.1 score on a scale | Standard Deviation 0.83 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | -0.5 score on a scale | Standard Deviation 0.93 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 2.6 score on a scale | Standard Deviation 0.65 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | -0.5 score on a scale | Standard Deviation 0.78 |
| Part A: E2006 5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | 0.2 score on a scale | Standard Deviation 0.92 |
| Part A: E2006 5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 2.6 score on a scale | Standard Deviation 0.7 |
| Part A: E2006 10 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 2.8 score on a scale | Standard Deviation 0.75 |
| Part A: E2006 10 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | -0.4 score on a scale | Standard Deviation 1 |
Primary
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6
Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Time spent awake after falling asleep has been reported.
Time frame: Day 1, Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 133.8 minutes | Standard Deviation 115.76 |
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -27.9 minutes | Standard Deviation 136.39 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 101.8 minutes | Standard Deviation 76.36 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -5.5 minutes | Standard Deviation 55.7 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 82.3 minutes | Standard Deviation 46.31 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -3.7 minutes | Standard Deviation 54.03 |
| Part A: E2006 5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | 46.8 minutes | Standard Deviation 140.47 |
| Part A: E2006 5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 102.0 minutes | Standard Deviation 68.56 |
| Part A: E2006 10 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 128.8 minutes | Standard Deviation 88.3 |
| Part A: E2006 10 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | 10.7 minutes | Standard Deviation 93.91 |
Primary
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6
Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Time to fall asleep last night has been reported.
Time frame: Day 1, Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 70.8 minutes | Standard Deviation 22.55 |
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | 8.3 minutes | Standard Deviation 36.33 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 67.3 minutes | Standard Deviation 30.36 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | 9.1 minutes | Standard Deviation 28.09 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 72.2 minutes | Standard Deviation 51.99 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | -3.8 minutes | Standard Deviation 31.37 |
| Part A: E2006 5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | 46.5 minutes | Standard Deviation 76.63 |
| Part A: E2006 5 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 82.5 minutes | Standard Deviation 61.02 |
| Part A: E2006 10 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 108.1 minutes | Standard Deviation 65 |
| Part A: E2006 10 mg | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | -13.7 minutes | Standard Deviation 42.57 |
Primary
Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6
DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function.
Time frame: Day 1 (Pre-dose), Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 9.8 score on a scale | Standard Deviation 15.15 |
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 53.0 score on a scale | Standard Deviation 9.56 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 10.5 score on a scale | Standard Deviation 14.44 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 50.7 score on a scale | Standard Deviation 11.64 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 48.2 score on a scale | Standard Deviation 10.8 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 14.3 score on a scale | Standard Deviation 13.34 |
| Part A: E2006 5 mg | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 51.0 score on a scale | Standard Deviation 6.48 |
| Part A: E2006 5 mg | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 8.3 score on a scale | Standard Deviation 15.33 |
| Part A: E2006 10 mg | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 11.7 score on a scale | Standard Deviation 20.67 |
| Part A: E2006 10 mg | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 49.5 score on a scale | Standard Deviation 11.87 |
Primary
Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6
PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment.
Time frame: Day 1 (Pre-dose), Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 2.3 lapses | Standard Deviation 3.67 |
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 0.3 lapses | Standard Deviation 2.49 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 3.0 lapses | Standard Deviation 2.86 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 2.3 lapses | Standard Deviation 6.84 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 4.1 lapses | Standard Deviation 7.57 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 0.9 lapses | Standard Deviation 5.33 |
| Part A: E2006 5 mg | Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | -1.4 lapses | Standard Deviation 3.66 |
| Part A: E2006 5 mg | Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 4.4 lapses | Standard Deviation 4.22 |
| Part A: E2006 10 mg | Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 5.2 lapses | Standard Deviation 12 |
| Part A: E2006 10 mg | Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | -1.2 lapses | Standard Deviation 9.57 |
Primary
Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6
KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 9, which indicates extremely sleepy, can't stay awake. Higher numbers indicating sleepier and lower numbers more alert.
Time frame: Day 1 (Pre-dose), Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Day 1 (Pre-dose) | 4.4 score on a scale | Standard Deviation 1.83 |
| Part A: E2006 Matched Placebo | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | -0.4 score on a scale | Standard Deviation 1.68 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Day 1 (Pre-dose) | 3.8 score on a scale | Standard Deviation 2.04 |
| Part A: E2006 1.0 mg | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 1.0 score on a scale | Standard Deviation 1.41 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Day 1 (Pre-dose) | 4.0 score on a scale | Standard Deviation 2.2 |
| Part A: E2006 2.5 mg | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 0.2 score on a scale | Standard Deviation 1.34 |
| Part A: E2006 5 mg | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | 0.3 score on a scale | Standard Deviation 1.95 |
| Part A: E2006 5 mg | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Day 1 (Pre-dose) | 4.8 score on a scale | Standard Deviation 2.2 |
| Part A: E2006 10 mg | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Day 1 (Pre-dose) | 5.5 score on a scale | Standard Deviation 1.93 |
| Part A: E2006 10 mg | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | Change From Day 1 (Pre-dose) at Day 6 | -0.7 score on a scale | Standard Deviation 2.27 |
Secondary
Part A: Apparent Total Clearance of E2006 From Plasma (CL/F)
Time frame: Day 1: Pre-dose, up to 240 hours post-dose
Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) | 44.8 liter per hour (L/h) | Geometric Coefficient of Variation 39 |
| Part A: E2006 1.0 mg | Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) | 28.2 liter per hour (L/h) | Geometric Coefficient of Variation 54.2 |
| Part A: E2006 2.5 mg | Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) | 33.9 liter per hour (L/h) | Geometric Coefficient of Variation 18.6 |
| Part A: E2006 5 mg | Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) | 33.4 liter per hour (L/h) | Geometric Coefficient of Variation 31.8 |
| Part A: E2006 10 mg | Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) | 17.0 liter per hour (L/h) | Geometric Coefficient of Variation 33.4 |
| Part A: E2006 25 mg | Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) | 24.8 liter per hour (L/h) | Geometric Coefficient of Variation 40.3 |
| Part A: E2006 50 mg | Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) | 22.1 liter per hour (L/h) | Geometric Coefficient of Variation 36.9 |
| Part A: E2006 100 mg | Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) | 20.2 liter per hour (L/h) | Geometric Coefficient of Variation 39.4 |
Secondary
Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F)
Time frame: Day 1: Pre-dose, up to 240 hours post-dose
Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) | 1170 liter (L) | Geometric Coefficient of Variation 40.7 |
| Part A: E2006 1.0 mg | Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) | 1200 liter (L) | Geometric Coefficient of Variation 34.4 |
| Part A: E2006 2.5 mg | Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) | 1610 liter (L) | Geometric Coefficient of Variation 25.3 |
| Part A: E2006 5 mg | Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) | 2670 liter (L) | Geometric Coefficient of Variation 26.6 |
| Part A: E2006 10 mg | Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) | 1580 liter (L) | Geometric Coefficient of Variation 24.5 |
| Part A: E2006 25 mg | Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) | 1810 liter (L) | Geometric Coefficient of Variation 28.7 |
| Part A: E2006 50 mg | Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) | 1930 liter (L) | Geometric Coefficient of Variation 28.1 |
| Part A: E2006 100 mg | Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) | 1680 liter (L) | Geometric Coefficient of Variation 35.4 |
Secondary
Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006
Time frame: Day 1: Pre-dose, up to 240 hours post-dose
Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameter for Part B were not analyzed due to change in planned analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 | 17.0 nanogram hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 17.5 |
| Part A: E2006 1.0 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 | 53.8 nanogram hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 36.4 |
| Part A: E2006 2.5 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 | 93.2 nanogram hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 18.9 |
| Part A: E2006 5 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 | 150 nanogram hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 38.9 |
| Part A: E2006 10 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 | 648 nanogram hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 15.4 |
| Part A: E2006 25 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 | 1060 nanogram hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 33 |
| Part A: E2006 50 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 | 1850 nanogram hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 33.8 |
| Part A: E2006 100 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 | 3970 nanogram hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 24.8 |
Secondary
Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006
Time frame: Day 1: Pre-dose, up to 240 hours post-dose
Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 | 19.5 ng*h/mL | Geometric Coefficient of Variation 19.8 |
| Part A: E2006 1.0 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 | 72.3 ng*h/mL | Geometric Coefficient of Variation 54.3 |
| Part A: E2006 2.5 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 | 146 ng*h/mL | Geometric Coefficient of Variation 20.9 |
| Part A: E2006 5 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 | 299 ng*h/mL | Geometric Coefficient of Variation 31.7 |
| Part A: E2006 10 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 | 1470 ng*h/mL | Geometric Coefficient of Variation 33.7 |
| Part A: E2006 25 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 | 2020 ng*h/mL | Geometric Coefficient of Variation 40.3 |
| Part A: E2006 50 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 | 4520 ng*h/mL | Geometric Coefficient of Variation 36.8 |
| Part A: E2006 100 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 | 9910 ng*h/mL | Geometric Coefficient of Variation 39.5 |
Secondary
Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006
Time frame: Day 1: Pre-dose, up to 240 hours post-dose
Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 | 18.4 ng*h/mL | Geometric Coefficient of Variation 29.9 |
| Part A: E2006 1.0 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 | 74.4 ng*h/mL | Geometric Coefficient of Variation 45.9 |
| Part A: E2006 2.5 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 | 126 ng*h/mL | Geometric Coefficient of Variation 18.7 |
| Part A: E2006 5 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 | 274 ng*h/mL | Geometric Coefficient of Variation 30.4 |
| Part A: E2006 10 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 | 1390 ng*h/mL | Geometric Coefficient of Variation 31.3 |
| Part A: E2006 25 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 | 1960 ng*h/mL | Geometric Coefficient of Variation 38.5 |
| Part A: E2006 50 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 | 4300 ng*h/mL | Geometric Coefficient of Variation 35.1 |
| Part A: E2006 100 mg | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 | 9290 ng*h/mL | Geometric Coefficient of Variation 39.5 |
Secondary
Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6
Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question How long did you sleep last night has been reported.
Time frame: Day 1, Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for the outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | 3.0 minutes | Standard Deviation 29.58 |
| Part A: E2006 Matched Placebo | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 457.7 minutes | Standard Deviation 24.81 |
| Part A: E2006 1.0 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 475.0 minutes | Standard Deviation 12.25 |
| Part A: E2006 2.5 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 443.3 minutes | Standard Deviation 42.39 |
| Part A: E2006 5 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 436.7 minutes | Standard Deviation 36.29 |
| Part A: E2006 10 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 473.3 minutes | Standard Deviation 7.53 |
| Part A: E2006 10 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | -85.8 minutes | Standard Deviation 82.12 |
| Part A: E2006 25 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 469.2 minutes | Standard Deviation 26.54 |
| Part A: E2006 25 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | 10.8 minutes | Standard Deviation 26.54 |
| Part A: E2006 50 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | 22.5 minutes | Standard Deviation 32.52 |
| Part A: E2006 50 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 438.3 minutes | Standard Deviation 21.37 |
| Part A: E2006 100 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 455.0 minutes | Standard Deviation 48.06 |
| Part A: E2006 100 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | -4.2 minutes | Standard Deviation 21.54 |
| Part A: E2006 200 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Change From Day 1 at Day 6 | -11.0 minutes | Standard Deviation 79.23 |
| Part A: E2006 200 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | Day 1 | 434.2 minutes | Standard Deviation 45.21 |
Secondary
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6
Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Number of awakening after falling asleep has been reported.
Time frame: Day 1, Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for the outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -0.6 number of awakenings | Standard Deviation 1.24 |
| Part A: E2006 Matched Placebo | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 1.1 number of awakenings | Standard Deviation 0.77 |
| Part A: E2006 1.0 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 1.8 number of awakenings | Standard Deviation 0.75 |
| Part A: E2006 2.5 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 1.3 number of awakenings | Standard Deviation 1.03 |
| Part A: E2006 5 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 0.8 number of awakenings | Standard Deviation 0.75 |
| Part A: E2006 10 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 0.5 number of awakenings | Standard Deviation 0.84 |
| Part A: E2006 10 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | 1.7 number of awakenings | Standard Deviation 1.97 |
| Part A: E2006 25 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 1.2 number of awakenings | Standard Deviation 0.98 |
| Part A: E2006 25 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | 0.3 number of awakenings | Standard Deviation 1.51 |
| Part A: E2006 50 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | 0.2 number of awakenings | Standard Deviation 0.41 |
| Part A: E2006 50 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 0.8 number of awakenings | Standard Deviation 0.98 |
| Part A: E2006 100 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 1.8 number of awakenings | Standard Deviation 0.41 |
| Part A: E2006 100 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -0.7 number of awakenings | Standard Deviation 1.03 |
| Part A: E2006 200 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -1.0 number of awakenings | Standard Deviation 1.79 |
| Part A: E2006 200 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | Day 1 | 1.8 number of awakenings | Standard Deviation 1.72 |
Secondary
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6
Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Rate quality of your sleep has been reported.
Time frame: Day 1, Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for the outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | 0.2 score on a scale | Standard Deviation 0.67 |
| Part A: E2006 Matched Placebo | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 1.1 score on a scale | Standard Deviation 0.77 |
| Part A: E2006 1.0 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 0.3 score on a scale | Standard Deviation 0.52 |
| Part A: E2006 2.5 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 1.5 score on a scale | Standard Deviation 1.22 |
| Part A: E2006 5 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 0.7 score on a scale | Standard Deviation 0.82 |
| Part A: E2006 10 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 1.0 score on a scale | Standard Deviation 0 |
| Part A: E2006 10 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | 1.3 score on a scale | Standard Deviation 1.03 |
| Part A: E2006 25 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 0.5 score on a scale | Standard Deviation 0.84 |
| Part A: E2006 25 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | 0.0 score on a scale | Standard Deviation 0 |
| Part A: E2006 50 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | 0.0 score on a scale | Standard Deviation 0 |
| Part A: E2006 50 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 1.0 score on a scale | Standard Deviation 0.89 |
| Part A: E2006 100 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 0.8 score on a scale | Standard Deviation 0.98 |
| Part A: E2006 100 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | 0.2 score on a scale | Standard Deviation 0.75 |
| Part A: E2006 200 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Change From Day 1 at Day 6 | -0.2 score on a scale | Standard Deviation 1.17 |
| Part A: E2006 200 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | Day 1 | 1.5 score on a scale | Standard Deviation 0.84 |
Secondary
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6
Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Time spent awake after falling asleep has been reported.
Time frame: Day 1, Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for the outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -1.9 minutes | Standard Deviation 8.18 |
| Part A: E2006 Matched Placebo | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 4.6 minutes | Standard Deviation 4.86 |
| Part A: E2006 1.0 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 6.2 minutes | Standard Deviation 3.76 |
| Part A: E2006 2.5 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 16.8 minutes | Standard Deviation 22.14 |
| Part A: E2006 5 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 5.3 minutes | Standard Deviation 7.53 |
| Part A: E2006 10 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 1.7 minutes | Standard Deviation 2.58 |
| Part A: E2006 10 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | 53.3 minutes | Standard Deviation 53.82 |
| Part A: E2006 25 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 5.0 minutes | Standard Deviation 4.47 |
| Part A: E2006 25 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | 5.0 minutes | Standard Deviation 8.37 |
| Part A: E2006 50 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | 5.0 minutes | Standard Deviation 4.65 |
| Part A: E2006 50 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 5.0 minutes | Standard Deviation 6.32 |
| Part A: E2006 100 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 11.2 minutes | Standard Deviation 5.6 |
| Part A: E2006 100 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -3.0 minutes | Standard Deviation 7.75 |
| Part A: E2006 200 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Change From Day 1 at Day 6 | -2.5 minutes | Standard Deviation 4.37 |
| Part A: E2006 200 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | Day 1 | 6.7 minutes | Standard Deviation 4.08 |
Secondary
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6
Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Time to fall asleep last night has been reported.
Time frame: Day 1, Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for the outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | 2.1 minutes | Standard Deviation 10.46 |
| Part A: E2006 Matched Placebo | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 13.2 minutes | Standard Deviation 6.99 |
| Part A: E2006 1.0 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 15.7 minutes | Standard Deviation 9.73 |
| Part A: E2006 2.5 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 17.2 minutes | Standard Deviation 9.91 |
| Part A: E2006 5 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 14.5 minutes | Standard Deviation 10.17 |
| Part A: E2006 10 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 15.0 minutes | Standard Deviation 8.94 |
| Part A: E2006 10 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | 20.0 minutes | Standard Deviation 39.37 |
| Part A: E2006 25 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 16.7 minutes | Standard Deviation 7.53 |
| Part A: E2006 25 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | -4.7 minutes | Standard Deviation 6.68 |
| Part A: E2006 50 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | -3.8 minutes | Standard Deviation 5.49 |
| Part A: E2006 50 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 15.8 minutes | Standard Deviation 3.76 |
| Part A: E2006 100 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 10.0 minutes | Standard Deviation 5.48 |
| Part A: E2006 100 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | 4.2 minutes | Standard Deviation 3.76 |
| Part A: E2006 200 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Change From Day 1 at Day 6 | 7.0 minutes | Standard Deviation 27.93 |
| Part A: E2006 200 mg | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | Day 1 | 15.0 minutes | Standard Deviation 7.07 |
Secondary
Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae)
Time frame: Day 1: Pre-dose, up to 120 hours post-dose
Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) | 0.000108 milligram (mg) | Geometric Coefficient of Variation 28.6 |
| Part A: E2006 1.0 mg | Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) | 0.0000777 milligram (mg) | Geometric Coefficient of Variation 126 |
| Part A: E2006 2.5 mg | Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) | 0.000667 milligram (mg) | Geometric Coefficient of Variation 153 |
| Part A: E2006 5 mg | Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) | 0.00141 milligram (mg) | Geometric Coefficient of Variation 47.4 |
| Part A: E2006 10 mg | Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) | 0.00788 milligram (mg) | Geometric Coefficient of Variation 72.1 |
| Part A: E2006 25 mg | Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) | 0.0113 milligram (mg) | Geometric Coefficient of Variation 23.1 |
| Part A: E2006 50 mg | Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) | 0.0307 milligram (mg) | Geometric Coefficient of Variation 65.5 |
| Part A: E2006 100 mg | Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) | 0.0402 milligram (mg) | Geometric Coefficient of Variation 56.8 |
Secondary
Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6
DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function. In this outcome measure, data for participants who received placebo matched to 1 mg, 2.5 mg, 5 mg E2006 and matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006, has been presented separately.
Time frame: Day 1 (Pre-dose), up to Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 53.7 score on a scale | Standard Deviation 13.84 |
| Part A: E2006 Matched Placebo | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 14.3 score on a scale | Standard Deviation 14.01 |
| Part A: E2006 1.0 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 59.1 score on a scale | Standard Deviation 15.27 |
| Part A: E2006 1.0 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 7.8 score on a scale | Standard Deviation 18.23 |
| Part A: E2006 2.5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 52.3 score on a scale | Standard Deviation 10.33 |
| Part A: E2006 2.5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 16.0 score on a scale | Standard Deviation 11.42 |
| Part A: E2006 5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 63.7 score on a scale | Standard Deviation 8.57 |
| Part A: E2006 5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 9.0 score on a scale | Standard Deviation 18.57 |
| Part A: E2006 10 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 8.8 score on a scale | Standard Deviation 18.81 |
| Part A: E2006 10 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 61.2 score on a scale | Standard Deviation 13.53 |
| Part A: E2006 25 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | -9.0 score on a scale | Standard Deviation 34.71 |
| Part A: E2006 25 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 60.5 score on a scale | Standard Deviation 9.97 |
| Part A: E2006 50 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 5.8 score on a scale | Standard Deviation 30.01 |
| Part A: E2006 50 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 59.2 score on a scale | Standard Deviation 8.06 |
| Part A: E2006 100 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 59.8 score on a scale | Standard Deviation 8.8 |
| Part A: E2006 100 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 2.6 score on a scale | Standard Deviation 27.57 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 56.5 score on a scale | Standard Deviation 8.57 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | -13.0 score on a scale | Standard Deviation 18.97 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Day 1 (Pre-dose) | 62.8 score on a scale | Standard Deviation 18.93 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | -16.3 score on a scale | Standard Deviation 34.62 |
Secondary
Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6
KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 9, which indicates extremely sleepy, can't stay awake. Higher numbers indicating sleepier and lower numbers more alert. In this outcome measure, data for participants who received placebo matched to 1 mg, 2.5 mg, 5 mg E2006 and matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006, has been presented separately.
Time frame: Day 1 (Pre-dose), Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose) | 5.2 score on a scale | Standard Deviation 1.83 |
| Part A: E2006 Matched Placebo | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | -0.8 score on a scale | Standard Deviation 4.02 |
| Part A: E2006 1.0 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose) | 2.8 score on a scale | Standard Deviation 1.48 |
| Part A: E2006 1.0 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 0.5 score on a scale | Standard Deviation 2.95 |
| Part A: E2006 2.5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose) | 3.2 score on a scale | Standard Deviation 0.98 |
| Part A: E2006 2.5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 0.0 score on a scale | Standard Deviation 2.55 |
| Part A: E2006 5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose) | 3.8 score on a scale | Standard Deviation 2.04 |
| Part A: E2006 5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | -0.2 score on a scale | Standard Deviation 3.13 |
| Part A: E2006 10 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 0.8 score on a scale | Standard Deviation 4.6 |
| Part A: E2006 10 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose) | 3.5 score on a scale | Standard Deviation 2.88 |
| Part A: E2006 25 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 5.3 score on a scale | Standard Deviation 1.21 |
| Part A: E2006 25 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose) | 3.0 score on a scale | Standard Deviation 1.1 |
| Part A: E2006 50 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 4.8 score on a scale | Standard Deviation 2.99 |
| Part A: E2006 50 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose) | 2.0 score on a scale | Standard Deviation 1.1 |
| Part A: E2006 100 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose) | 2.3 score on a scale | Standard Deviation 2.07 |
| Part A: E2006 100 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 5.4 score on a scale | Standard Deviation 3.44 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose) | 2.2 score on a scale | Standard Deviation 0.98 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 6.0 score on a scale | Standard Deviation 1.26 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Day 1 (Pre-dose) | 2.5 score on a scale | Standard Deviation 1.52 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 6.3 score on a scale | Standard Deviation 1.86 |
Secondary
Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6
PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment. In this outcome measure, data for participants who received placebo matched to 1 mg, 2.5 mg, 5 mg E2006 and matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006, has been presented separately.
Time frame: Day 1 (Pre-dose), Day 6
Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 1.0 lapses | Standard Deviation 0.89 |
| Part A: E2006 Matched Placebo | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 6.0 lapses | Standard Deviation 10.7 |
| Part A: E2006 1.0 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 1.8 lapses | Standard Deviation 2.39 |
| Part A: E2006 1.0 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 4.7 lapses | Standard Deviation 3.37 |
| Part A: E2006 2.5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 1.3 lapses | Standard Deviation 2.42 |
| Part A: E2006 2.5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 3.4 lapses | Standard Deviation 2.07 |
| Part A: E2006 5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 2.5 lapses | Standard Deviation 2.43 |
| Part A: E2006 5 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 1.4 lapses | Standard Deviation 4.45 |
| Part A: E2006 10 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 2.5 lapses | Standard Deviation 9.33 |
| Part A: E2006 10 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 1.3 lapses | Standard Deviation 1.97 |
| Part A: E2006 25 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 22.6 lapses | Standard Deviation 10.45 |
| Part A: E2006 25 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 1.5 lapses | Standard Deviation 1.38 |
| Part A: E2006 50 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 19.7 lapses | Standard Deviation 19.5 |
| Part A: E2006 50 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 0.3 lapses | Standard Deviation 0.52 |
| Part A: E2006 100 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 2.5 lapses | Standard Deviation 2.07 |
| Part A: E2006 100 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 26.6 lapses | Standard Deviation 12.42 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 2.0 lapses | Standard Deviation 1.9 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 29.2 lapses | Standard Deviation 14.13 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Day 1 (Pre-dose) | 6.5 lapses | Standard Deviation 4.18 |
| Part A: E2006 200 mg | Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 | Maximum Change From Day 1 (Pre-dose) at Day 6 | 32.0 lapses | Standard Deviation 16.63 |
Secondary
Part A: Maximum Plasma Concentration (Cmax) of E2006
Time frame: Day 1: Pre-dose, up to 240 hours post-dose
Population: Pharmacokinetic (PK) analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Maximum Plasma Concentration (Cmax) of E2006 | 5.15 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 27.1 |
| Part A: E2006 1.0 mg | Part A: Maximum Plasma Concentration (Cmax) of E2006 | 14.9 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
| Part A: E2006 2.5 mg | Part A: Maximum Plasma Concentration (Cmax) of E2006 | 22.3 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 19.1 |
| Part A: E2006 5 mg | Part A: Maximum Plasma Concentration (Cmax) of E2006 | 32.0 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 57.3 |
| Part A: E2006 10 mg | Part A: Maximum Plasma Concentration (Cmax) of E2006 | 107 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 20.3 |
| Part A: E2006 25 mg | Part A: Maximum Plasma Concentration (Cmax) of E2006 | 161 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 32.9 |
| Part A: E2006 50 mg | Part A: Maximum Plasma Concentration (Cmax) of E2006 | 242 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 47 |
| Part A: E2006 100 mg | Part A: Maximum Plasma Concentration (Cmax) of E2006 | 429 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 12.2 |
Secondary
Part A: Renal Clearance (CLR) of Drug E2006
Time frame: Day 1: Pre-dose, up to 120 hours post-dose
Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Renal Clearance (CLR) of Drug E2006 | 0.0877 milliliter per minute (mL/min) | Geometric Coefficient of Variation 29.8 |
| Part A: E2006 1.0 mg | Part A: Renal Clearance (CLR) of Drug E2006 | 0.0157 milliliter per minute (mL/min) | Geometric Coefficient of Variation 70.7 |
| Part A: E2006 2.5 mg | Part A: Renal Clearance (CLR) of Drug E2006 | 0.0881 milliliter per minute (mL/min) | Geometric Coefficient of Variation 129 |
| Part A: E2006 5 mg | Part A: Renal Clearance (CLR) of Drug E2006 | 0.0938 milliliter per minute (mL/min) | Geometric Coefficient of Variation 68.7 |
| Part A: E2006 10 mg | Part A: Renal Clearance (CLR) of Drug E2006 | 0.111 milliliter per minute (mL/min) | Geometric Coefficient of Variation 66.2 |
| Part A: E2006 25 mg | Part A: Renal Clearance (CLR) of Drug E2006 | 0.107 milliliter per minute (mL/min) | Geometric Coefficient of Variation 34.5 |
| Part A: E2006 50 mg | Part A: Renal Clearance (CLR) of Drug E2006 | 0.140 milliliter per minute (mL/min) | Geometric Coefficient of Variation 44.6 |
| Part A: E2006 100 mg | Part A: Renal Clearance (CLR) of Drug E2006 | 0.0844 milliliter per minute (mL/min) | Geometric Coefficient of Variation 41.7 |
Secondary
Part A: Terminal Half-life (t1/2) of E2006 in Plasma
Time frame: Day 1: Pre-dose, up to 240 hours post-dose
Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Terminal Half-life (t1/2) of E2006 in Plasma | 12.700 hours |
| Part A: E2006 1.0 mg | Part A: Terminal Half-life (t1/2) of E2006 in Plasma | 30.100 hours |
| Part A: E2006 2.5 mg | Part A: Terminal Half-life (t1/2) of E2006 in Plasma | 31.350 hours |
| Part A: E2006 5 mg | Part A: Terminal Half-life (t1/2) of E2006 in Plasma | 56.150 hours |
| Part A: E2006 10 mg | Part A: Terminal Half-life (t1/2) of E2006 in Plasma | 65.500 hours |
| Part A: E2006 25 mg | Part A: Terminal Half-life (t1/2) of E2006 in Plasma | 51.850 hours |
| Part A: E2006 50 mg | Part A: Terminal Half-life (t1/2) of E2006 in Plasma | 59.750 hours |
| Part A: E2006 100 mg | Part A: Terminal Half-life (t1/2) of E2006 in Plasma | 65.200 hours |
Secondary
Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006
Time frame: Day 1: Pre-dose, up to 240 hours post-dose
Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: E2006 Matched Placebo | Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 | 1.000 hours |
| Part A: E2006 1.0 mg | Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 | 1.010 hours |
| Part A: E2006 2.5 mg | Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 | 1.550 hours |
| Part A: E2006 5 mg | Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 | 1.000 hours |
| Part A: E2006 10 mg | Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 | 2.010 hours |
| Part A: E2006 25 mg | Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 | 2.525 hours |
| Part A: E2006 50 mg | Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 | 3.000 hours |
| Part A: E2006 100 mg | Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 | 3.000 hours |
Secondary
Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess any suicidality, any suicidal Behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is yes for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious, behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is yes for any of these questions-wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of participants with any suicidality has been reported for this outcome measure.
Time frame: Baseline, Day 11
Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 2 Participants |
| Part A: E2006 Matched Placebo | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 1.0 mg | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 1.0 mg | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 2.5 mg | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 2.5 mg | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 5 mg | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
| Part A: E2006 5 mg | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 10 mg | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 0 Participants |
| Part A: E2006 10 mg | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 11 | 0 Participants |
Secondary
Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values
Time frame: Baseline up to Day 11
Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values | 0 Participants |
| Part A: E2006 1.0 mg | Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values | 0 Participants |
| Part A: E2006 2.5 mg | Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values | 0 Participants |
| Part A: E2006 5 mg | Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values | 0 Participants |
| Part A: E2006 10 mg | Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values | 0 Participants |
Secondary
Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values
Time frame: Baseline up to Day 6
Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 3 Participants |
| Part A: E2006 1.0 mg | Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 6 Participants |
| Part A: E2006 2.5 mg | Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 4 Participants |
| Part A: E2006 5 mg | Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 3 Participants |
| Part A: E2006 10 mg | Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values | 7 Participants |
Secondary
Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values
Time frame: Baseline up to Day 11
Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 1.0 mg | Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 2.5 mg | Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 5 mg | Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Part A: E2006 10 mg | Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values | 0 Participants |
Secondary
Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 11
Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: E2006 Matched Placebo | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 Matched Placebo | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 1 Participants |
| Part A: E2006 1.0 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 1.0 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 6 Participants |
| Part A: E2006 2.5 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 2 Participants |
| Part A: E2006 2.5 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 5 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 6 Participants |
| Part A: E2006 5 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 10 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: E2006 10 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | AEs | 6 Participants |