Trial Outcomes & Findings for Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation (NCT NCT04035200)
NCT ID: NCT04035200
Last Updated: 2023-09-18
Results Overview
Wakefulness After Sleep Onset, as measured by PSG, was defined as wake time after persistent sleep (wake time during sleep plus wake time after sleep, expressed in minutes). Nights 1 / 2 is the average of the PSG measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the PSG measurements taken during nights 20 and 21 of study drug exposure.
COMPLETED
PHASE2
114 participants
Baseline, Nights 1 / 2, Nights 20 / 21
2023-09-18
Participant Flow
This was a multi-center study conducted at study sites in the US.
Participant milestones
| Measure |
V117957 1 mg
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
38
|
|
Overall Study
COMPLETED
|
36
|
31
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
4
|
Reasons for withdrawal
| Measure |
V117957 1 mg
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
4
|
|
Overall Study
COVID-19
|
1
|
0
|
0
|
|
Overall Study
Early Termination
|
0
|
1
|
0
|
|
Overall Study
Non-compliance
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
Baseline characteristics by cohort
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 12.85 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 13.01 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 12.18 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 12.60 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Wakefulness After Sleep Onset, as measured by PSG, was defined as wake time after persistent sleep (wake time during sleep plus wake time after sleep, expressed in minutes). Nights 1 / 2 is the average of the PSG measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the PSG measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG)
Baseline
|
100.88 Minutes
Standard Deviation 45.098
|
99.70 Minutes
Standard Deviation 36.496
|
103.51 Minutes
Standard Deviation 32.456
|
|
Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG)
Nights 1 / 2
|
48.64 Minutes
Standard Deviation 28.453
|
42.44 Minutes
Standard Deviation 28.189
|
63.00 Minutes
Standard Deviation 29.349
|
|
Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG)
Nights 20 / 21
|
50.56 Minutes
Standard Deviation 34.115
|
46.17 Minutes
Standard Deviation 27.275
|
64.43 Minutes
Standard Deviation 33.999
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Sleep efficiency, as measured by PSG, is defined as Total Sleep Time (TST), divided by total recording time, multiplied by 100. Nights 1 / 2 is the average of the PSG measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the PSG measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Mean Sleep Efficiency (SE)
Baseline
|
64.54 Percent
Standard Deviation 11.502
|
67.18 Percent
Standard Deviation 9.919
|
63.17 Percent
Standard Deviation 12.825
|
|
Change From Baseline in Mean Sleep Efficiency (SE)
Nights 1 / 2
|
82.00 Percent
Standard Deviation 10.810
|
85.55 Percent
Standard Deviation 7.953
|
77.64 Percent
Standard Deviation 9.950
|
|
Change From Baseline in Mean Sleep Efficiency (SE)
Nights 20 / 21
|
79.46 Percent
Standard Deviation 10.516
|
84.89 Percent
Standard Deviation 7.456
|
78.38 Percent
Standard Deviation 8.890
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Latency to onset of persistent sleep (LPS), as measured by PSG, is defined as time from lights-off to the first of 20 consecutive periods of non-wake sleep stages. Latency to persistent sleep is reported in minutes. Nights 1 / 2 is the average of the PSG measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the PSG measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Mean Latency to Persistent Sleep (LPS)
Baseline
|
76.63 Minutes
Standard Deviation 34.305
|
66.30 Minutes
Standard Deviation 25.653
|
81.58 Minutes
Standard Deviation 48.928
|
|
Change From Baseline in Mean Latency to Persistent Sleep (LPS)
Nights 1 / 2
|
43.03 Minutes
Standard Deviation 38.542
|
31.31 Minutes
Standard Deviation 20.593
|
51.74 Minutes
Standard Deviation 37.243
|
|
Change From Baseline in Mean Latency to Persistent Sleep (LPS)
Nights 20 / 21
|
53.48 Minutes
Standard Deviation 47.123
|
31.70 Minutes
Standard Deviation 25.709
|
47.42 Minutes
Standard Deviation 31.165
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Total sleep time, as measured by PSG, is the duration of rapid eye movement (REM) plus NREM (stages N1 + N2 + N3) during time in bed. Nights 1 / 2 is the average of the PSG measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the PSG measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Mean Total Sleep Time (TST)
Baseline
|
309.87 Minutes
Standard Deviation 55.265
|
323.11 Minutes
Standard Deviation 48.065
|
303.24 Minutes
Standard Deviation 61.559
|
|
Change From Baseline in Mean Total Sleep Time (TST)
Nights 1 / 2
|
393.80 Minutes
Standard Deviation 51.677
|
410.12 Minutes
Standard Deviation 38.771
|
372.68 Minutes
Standard Deviation 47.771
|
|
Change From Baseline in Mean Total Sleep Time (TST)
Nights 20 / 21
|
381.65 Minutes
Standard Deviation 50.528
|
407.45 Minutes
Standard Deviation 35.765
|
376.26 Minutes
Standard Deviation 42.640
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Sleep component as measured by PSG. Number of awakenings is determined from persistent sleep to lights-on. An awakening is defined as a PSG recording of at least 2 consecutive wake periods. Nights 1 / 2 is the average of the PSG measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the PSG measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Awakenings (NAW)
Baseline
|
10.70 Number of Awakenings
Standard Deviation 5.733
|
14.05 Number of Awakenings
Standard Deviation 5.101
|
10.32 Number of Awakenings
Standard Deviation 5.609
|
|
Change From Baseline in Mean Number of Awakenings (NAW)
Nights 1 / 2
|
8.25 Number of Awakenings
Standard Deviation 3.860
|
9.62 Number of Awakenings
Standard Deviation 5.599
|
10.20 Number of Awakenings
Standard Deviation 4.256
|
|
Change From Baseline in Mean Number of Awakenings (NAW)
Nights 20 / 21
|
9.29 Number of Awakenings
Standard Deviation 5.114
|
10.63 Number of Awakenings
Standard Deviation 6.055
|
10.28 Number of Awakenings
Standard Deviation 5.575
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Self-reported sleep outcome measured by subject diary data. Scores have a range of 1 to 5, with 1 being equal to "Very Poor" and 5 being equal to "'Very Good." Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Subjective Sleep Quality (sSleep)
Baseline
|
1.80 score on a scale
Standard Deviation 0.686
|
1.82 score on a scale
Standard Deviation 0.683
|
1.99 score on a scale
Standard Deviation 0.727
|
|
Change From Baseline in Subjective Sleep Quality (sSleep)
Nights 1 / 2
|
2.72 score on a scale
Standard Deviation 0.984
|
2.92 score on a scale
Standard Deviation 1.004
|
2.64 score on a scale
Standard Deviation 0.734
|
|
Change From Baseline in Subjective Sleep Quality (sSleep)
Nights 20 / 21
|
2.94 score on a scale
Standard Deviation 0.989
|
3.11 score on a scale
Standard Deviation 1.027
|
3.20 score on a scale
Standard Deviation 0.841
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Self-reported sleep outcome measured by subject diary data. Total sleep time is reported in minutes. Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Subjective Total Sleep Time (sTST)
Baseline
|
296.42 Minutes
Standard Deviation 45.586
|
304.60 Minutes
Standard Deviation 50.458
|
315.05 Minutes
Standard Deviation 56.092
|
|
Change From Baseline in Subjective Total Sleep Time (sTST)
Nights 1 / 2
|
355.82 Minutes
Standard Deviation 69.903
|
357.35 Minutes
Standard Deviation 80.198
|
350.64 Minutes
Standard Deviation 51.843
|
|
Change From Baseline in Subjective Total Sleep Time (sTST)
Nights 20 / 21
|
366.14 Minutes
Standard Deviation 59.562
|
385.13 Minutes
Standard Deviation 71.181
|
384.13 Minutes
Standard Deviation 58.830
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: \\Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Self-reported sleep outcome measured by subject diary data. WASO is defined as wake time after persistent sleep (wake time during sleep plus wake time after sleep, expressed in minutes). Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO)
Baseline
|
92.51 Minutes
Standard Deviation 42.137
|
85.93 Minutes
Standard Deviation 42.222
|
83.49 Minutes
Standard Deviation 63.929
|
|
Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO)
Nights 1 / 2
|
63.77 Minutes
Standard Deviation 63.476
|
59.48 Minutes
Standard Deviation 55.546
|
55.72 Minutes
Standard Deviation 34.974
|
|
Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO)
Nights 20 / 21
|
51.53 Minutes
Standard Deviation 40.574
|
54.21 Minutes
Standard Deviation 44.666
|
46.84 Minutes
Standard Deviation 32.499
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Self-reported sleep outcome measured by subject diary data. Sleep onset latency (SOL) is the time it takes to fall asleep after turning the lights out. Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Subjective Sleep Onset Latency (sSOL)
Baseline
|
74.54 Minutes
Standard Deviation 30.022
|
75.84 Minutes
Standard Deviation 31.274
|
63.45 Minutes
Standard Deviation 19.795
|
|
Change From Baseline in Subjective Sleep Onset Latency (sSOL)
Nights 1 / 2
|
54.42 Minutes
Standard Deviation 29.031
|
50.53 Minutes
Standard Deviation 32.579
|
57.24 Minutes
Standard Deviation 28.375
|
|
Change From Baseline in Subjective Sleep Onset Latency (sSOL)
Nights 20 / 21
|
63.13 Minutes
Standard Deviation 32.740
|
47.14 Minutes
Standard Deviation 24.289
|
47.68 Minutes
Standard Deviation 33.170
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Self-reported sleep outcome measured by subject diary data. Sleep efficiency (SE) is calculated by dividing the time asleep by the total time in bed multiplied by 100 (SE is reported as percent). Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Subjective Sleep Efficiency (sSE)
Baseline
|
61.51 Percent
Standard Deviation 8.768
|
63.14 Percent
Standard Deviation 8.898
|
63.50 Percent
Standard Deviation 10.924
|
|
Change From Baseline in Subjective Sleep Efficiency (sSE)
Nights 1 / 2
|
73.26 Percent
Standard Deviation 14.436
|
73.72 Percent
Standard Deviation 16.661
|
71.53 Percent
Standard Deviation 10.229
|
|
Change From Baseline in Subjective Sleep Efficiency (sSE)
Nights 20 / 21
|
73.74 Percent
Standard Deviation 11.925
|
76.78 Percent
Standard Deviation 12.383
|
75.88 Percent
Standard Deviation 11.743
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Self-reported sleep outcome measured by subject diary data. The subject recorded the number of awakenings in the diary. Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Subjective Number of Awakenings (sNAW)
Baseline
|
2.49 Number of Awakenings
Standard Deviation 1.100
|
2.24 Number of Awakenings
Standard Deviation 1.013
|
2.37 Number of Awakenings
Standard Deviation 0.984
|
|
Change From Baseline in Subjective Number of Awakenings (sNAW)
Nights 1 / 2
|
1.87 Number of Awakenings
Standard Deviation 1.245
|
2.14 Number of Awakenings
Standard Deviation 2.703
|
2.63 Number of Awakenings
Standard Deviation 1.647
|
|
Change From Baseline in Subjective Number of Awakenings (sNAW)
Nights 20 / 21
|
1.42 Number of Awakenings
Standard Deviation 1.049
|
1.30 Number of Awakenings
Standard Deviation 0.815
|
1.66 Number of Awakenings
Standard Deviation 1.405
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Self-reported sleep outcome measured by subject diary data. Individual scores have a range of 1 to 5, with 1 being equal to "Not at All Rested" and 5 being equal to "Very Well Rested." Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Change From Baseline in Subjective Morning Sleepiness on Awakening
Baseline
|
1.54 score on a scale
Standard Deviation 0.655
|
1.60 score on a scale
Standard Deviation 0.613
|
1.72 score on a scale
Standard Deviation 0.611
|
|
Change From Baseline in Subjective Morning Sleepiness on Awakening
Nights 1 /2
|
2.23 score on a scale
Standard Deviation 0.870
|
2.19 score on a scale
Standard Deviation 0.847
|
2.24 score on a scale
Standard Deviation 0.695
|
|
Change From Baseline in Subjective Morning Sleepiness on Awakening
Nights 20 / 21
|
2.52 score on a scale
Standard Deviation 0.979
|
2.69 score on a scale
Standard Deviation 1.158
|
2.81 score on a scale
Standard Deviation 0.937
|
SECONDARY outcome
Timeframe: Nights 1 / 2, Nights 20 / 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
The proportion of responders is based on subjects meeting or exceeding WASO (wakefulness after sleep onset) 15 minute threshold as derived from polysomnography (PSG). Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo
Responder - Nights 1 / 2 - Threshold 15 minutes
|
29 Participants
|
33 Participants
|
30 Participants
|
|
Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo
Responder - Nights 20 / 21 - Threshold 15 minutes
|
33 Participants
|
27 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline Compared to Washout/Follow-up Period (Nights 22 / 23)Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
Rebound insomnia is defined as a worsening of sleep compared with pretreatment. The comparison is based on the Wakefulness After Sleep Onset (WASO) measured by PSG of the Washout/Follow-up Period versus Baseline. If the LS means for WASO for the Washout/Follow-up Period is lower than Baseline, then no rebound insomnia was suggested. Nights 22 / 23 is the average of the measurements taken during nights 22 and 23 (Washout Period).
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Occurrence of Rebound Insomnia During the Washout/Follow-up Period
Baseline
|
100.88 Minutes
Standard Deviation 45.098
|
99.70 Minutes
Standard Deviation 36.496
|
103.51 Minutes
Standard Deviation 32.456
|
|
Occurrence of Rebound Insomnia During the Washout/Follow-up Period
Washout/Follow-up Period
|
78.82 Minutes
Standard Deviation 48.048
|
94.23 Minutes
Standard Deviation 58.961
|
65.03 Minutes
Standard Deviation 33.942
|
SECONDARY outcome
Timeframe: Baseline, Night 2, Night 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
The DSST explores attention and psychomotor speed by measuring total correct responses. The maximum score is 165. Higher scores represent better outcome/improvement.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST).
Baseline - Total correct responses
|
49.0 Correct Responses
Standard Deviation 17.82
|
46.4 Correct Responses
Standard Deviation 15.85
|
46.2 Correct Responses
Standard Deviation 18.95
|
|
Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST).
Night 2;10-hours postdose - Total correct responses
|
51.6 Correct Responses
Standard Deviation 16.06
|
51.7 Correct Responses
Standard Deviation 13.83
|
54.8 Correct Responses
Standard Deviation 13.58
|
|
Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST).
Night 21; 10-hours postdose - Total correct responses
|
52.0 Correct Responses
Standard Deviation 16.67
|
52.6 Correct Responses
Standard Deviation 18.65
|
54.3 Correct Responses
Standard Deviation 15.66
|
SECONDARY outcome
Timeframe: Baseline, Night 2 (9- and 10-hours postdose), Night 21 (9- and 10-hours postdose)Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
The KSS is a 9-point Likert scale (range: 1 = "extremely alert" to 9 = "very sleepy") that measures level of sleepiness.
Outcome measures
| Measure |
V117957 1 mg
n=34 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=32 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=32 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS)
Baseline
|
4.3 score on a scale
Standard Deviation 2.30
|
4.4 score on a scale
Standard Deviation 2.23
|
4.4 score on a scale
Standard Deviation 2.09
|
|
Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS)
Night 2 - 9 hours postdose
|
4.2 score on a scale
Standard Deviation 1.94
|
4.7 score on a scale
Standard Deviation 2.17
|
4.3 score on a scale
Standard Deviation 2.06
|
|
Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS)
Night 2 - 10 hours postdose
|
3.8 score on a scale
Standard Deviation 1.94
|
4.0 score on a scale
Standard Deviation 2.03
|
3.9 score on a scale
Standard Deviation 1.93
|
|
Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS)
Night 21 - 9 hours postdose
|
4.1 score on a scale
Standard Deviation 1.99
|
4.5 score on a scale
Standard Deviation 2.34
|
3.9 score on a scale
Standard Deviation 1.75
|
|
Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS)
Night 21 - 10 hours postdose
|
3.8 score on a scale
Standard Deviation 2.02
|
4.0 score on a scale
Standard Deviation 1.88
|
3.1 score on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline, Night 2, Night 21Population: Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement.
The POMS-Brief contains 30 questions that assess mood states. Scores for each question range 0 = not at all to 4 = extremely. Total mood disturbance assessment is the total of the subject's subscales scores on anger/hostility, confusion/bewilderment, depression/dejection, fatigue/inertia, tension/anxiety, and vigor/activity. Total scores range from 0-120 and a higher total score indicates more mood disturbance.
Outcome measures
| Measure |
V117957 1 mg
n=38 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=37 Participants
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 Participants
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief
Baseline
|
13.54 score on a scale
Standard Deviation 23.612
|
12.03 score on a scale
Standard Deviation 15.658
|
11.80 score on a scale
Standard Deviation 16.863
|
|
Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief
Night 2
|
5.41 score on a scale
Standard Deviation 16.732
|
5.46 score on a scale
Standard Deviation 14.674
|
6.34 score on a scale
Standard Deviation 15.905
|
|
Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief
Night 21
|
2.02 score on a scale
Standard Deviation 15.075
|
5.22 score on a scale
Standard Deviation 13.630
|
1.58 score on a scale
Standard Deviation 16.305
|
Adverse Events
V117957 1 mg
V117957 2 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
V117957 1 mg
n=38 participants at risk
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
V117957 2 mg
n=38 participants at risk
V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime
|
Placebo
n=38 participants at risk
Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
5.3%
2/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
26.3%
10/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
0.00%
0/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
|
Nervous system disorders
Headache
|
7.9%
3/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
2.6%
1/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
5.3%
2/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
|
Gastrointestinal disorders
Nausea
|
5.3%
2/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
2.6%
1/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
7.9%
3/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
|
General disorders
Fatigue
|
0.00%
0/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
5.3%
2/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
5.3%
2/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
0.00%
0/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
5.3%
2/38 • Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place