Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder (NCT NCT03375203)
NCT ID: NCT03375203
Last Updated: 2025-04-29
Results Overview
Change in LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement.
COMPLETED
PHASE2
365 participants
Baseline and Night 1
2025-04-29
Participant Flow
Total of 365 participants were randomized and 364 participants were treated. 1 participant was randomized in error, never received any study drug and was excluded from the analyses. Among 364 treated participants,1 participant randomized to JNJ-42847922 10 mg group, received 5 mg of JNJ-42847922 and was summarized under 5 mg group for safety analyses, and under 10 mg dose group for all other analyses.
Participant milestones
| Measure |
Placebo
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
72
|
74
|
71
|
73
|
|
Overall Study
COMPLETED
|
69
|
68
|
72
|
69
|
69
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
2
|
2
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
3
|
0
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
1
|
0
|
2
|
|
Overall Study
Non-compliance with study drug
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Randomized, not treated.
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=74 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
Total
n=364 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 11.49 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 13.85 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 11.88 • n=4 Participants
|
58.5 years
STANDARD_DEVIATION 12.03 • n=21 Participants
|
57.8 years
STANDARD_DEVIATION 12.4 • n=10 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
Adults (18-64 years)
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
238 Participants
n=10 Participants
|
|
Age, Customized
From 65 to 84 years
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
126 Participants
n=10 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
246 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
118 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
53 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
310 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
73 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
251 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and Night 1Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Change in LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1
|
-15.24 Minutes
Standard Deviation 78.547 • Interval 78.547 to
|
-29.92 Minutes
Standard Deviation 49.049 • Interval 49.049 to
|
-49.49 Minutes
Standard Deviation 53.216 • Interval 53.216 to
|
-47.69 Minutes
Standard Deviation 48.423 • Interval 48.423 to
|
-40.74 Minutes
Standard Deviation 54.395 • Interval 54.395 to
|
SECONDARY outcome
Timeframe: Baseline and over first 6 hours on Night 1Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 1. Negative changes in WASO indicate improvement.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1
|
-15.05 Minutes
Standard Deviation 57.485 • Interval 57.485 to
|
-22.70 Minutes
Standard Deviation 45.904 • Interval 45.904 to
|
-42.57 Minutes
Standard Deviation 40.011 • Interval 40.011 to
|
-44.69 Minutes
Standard Deviation 42.823 • Interval 42.823 to
|
-29.04 Minutes
Standard Deviation 46.779 • Interval 46.779 to
|
SECONDARY outcome
Timeframe: Baseline and Night 13Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
LPS was measured on Night 13 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. Negative changes in LPS indicate improvement.
Outcome measures
| Measure |
Placebo
n=69 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=69 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=69 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=69 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in LPS as Measured by PSG on Night 13
|
-23.74 Minutes
Standard Deviation 61.790 • Interval 61.79 to
|
-27.12 Minutes
Standard Deviation 54.726 • Interval 54.726 to
|
-53.99 Minutes
Standard Deviation 60.292 • Interval 60.292 to
|
-41.19 Minutes
Standard Deviation 59.713 • Interval 59.713 to
|
-30.94 Minutes
Standard Deviation 60.236 • Interval 60.236 to
|
SECONDARY outcome
Timeframe: Baseline and over first 6 hours on Night 13Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 13. Negative changes in WASO indicate improvement.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=69 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=68 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=69 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13
|
-17.80 Minutes
Standard Deviation 52.369 • Interval 52.369 to
|
-14.63 Minutes
Standard Deviation 57.207 • Interval 57.207 to
|
-30.74 Minutes
Standard Deviation 52.835 • Interval 52.835 to
|
-38.40 Minutes
Standard Deviation 53.661 • Interval 53.661 to
|
-20.22 Minutes
Standard Deviation 46.465 • Interval 46.465 to
|
SECONDARY outcome
Timeframe: Baseline, Over 6 hours on Nights 1 and 13Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13
Night 1
|
25.50 Minutes
Standard Deviation 72.146
|
43.26 Minutes
Standard Deviation 50.771
|
76.47 Minutes
Standard Deviation 50.711
|
80.49 Minutes
Standard Deviation 56.216
|
53.70 Minutes
Standard Deviation 57.688
|
|
Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13
Night 13
|
33.16 Minutes
Standard Deviation 71.488
|
39.80 Minutes
Standard Deviation 66.556
|
66.03 Minutes
Standard Deviation 62.995
|
67.66 Minutes
Standard Deviation 66.254
|
35.84 Minutes
Standard Deviation 64.950
|
SECONDARY outcome
Timeframe: Baseline, Over 8 hours on Nights 1 and 13Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13
Night 13
|
38.45 Minutes
Standard Deviation 83.177
|
45.72 Minutes
Standard Deviation 72.640
|
64.84 Minutes
Standard Deviation 77.358
|
64.27 Minutes
Standard Deviation 82.377
|
39.26 Minutes
Standard Deviation 77.773
|
|
Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13
Night 1
|
37.03 Minutes
Standard Deviation 86.539
|
47.85 Minutes
Standard Deviation 64.499
|
81.20 Minutes
Standard Deviation 60.607
|
81.07 Minutes
Standard Deviation 71.581
|
63.88 Minutes
Standard Deviation 59.115
|
SECONDARY outcome
Timeframe: Baseline, Nights 1 and 13Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
Sleep efficiency was measured as the total sleep time divided by the total time in bed (that is, the number of hours from the beginning of the Polysomnography recording to the end of the recording) (in percentage). Positive changes in SE indicate improvement.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13
Night 13
|
7.99 Percentage of efficient sleep
Standard Deviation 17.322
|
9.51 Percentage of efficient sleep
Standard Deviation 15.154
|
13.67 Percentage of efficient sleep
Standard Deviation 16.037
|
13.56 Percentage of efficient sleep
Standard Deviation 17.199
|
8.27 Percentage of efficient sleep
Standard Deviation 16.323
|
|
Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13
Night 1
|
7.74 Percentage of efficient sleep
Standard Deviation 18.031
|
10.18 Percentage of efficient sleep
Standard Deviation 12.818
|
16.92 Percentage of efficient sleep
Standard Deviation 12.626
|
16.86 Percentage of efficient sleep
Standard Deviation 14.963
|
13.29 Percentage of efficient sleep
Standard Deviation 12.317
|
SECONDARY outcome
Timeframe: Baseline, Days 1 and 13 (Hours 1 to 8)Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
Polysomnography was used to measure the time to wake after initial sleep onset measured hourly on Day 1 and 13 from Hour 1 to Hour 8. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over 8 hours of PSG assessment. Negative changes in WASO indicate improvement.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 7): Day 1
|
-5.01 Minutes
Standard Deviation 22.247
|
-5.71 Minutes
Standard Deviation 19.784
|
-3.84 Minutes
Standard Deviation 16.756
|
-1.61 Minutes
Standard Deviation 19.349
|
-6.15 Minutes
Standard Deviation 13.756
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 3): Day 1
|
-5.57 Minutes
Standard Deviation 18.316
|
-3.91 Minutes
Standard Deviation 12.037
|
-11.05 Minutes
Standard Deviation 13.272
|
-9.64 Minutes
Standard Deviation 13.055
|
-9.62 Minutes
Standard Deviation 14.141
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 3): Day 13
|
-5.70 Minutes
Standard Deviation 17.681
|
-0.31 Minutes
Standard Deviation 18.562
|
-8.10 Minutes
Standard Deviation 12.446
|
-6.99 Minutes
Standard Deviation 15.331
|
-5.12 Minutes
Standard Deviation 18.140
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 4): Day 1
|
-5.33 Minutes
Standard Deviation 17.109
|
-4.73 Minutes
Standard Deviation 13.193
|
-9.67 Minutes
Standard Deviation 14.495
|
-9.74 Minutes
Standard Deviation 14.727
|
-6.23 Minutes
Standard Deviation 16.471
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 4): Day 13
|
-5.49 Minutes
Standard Deviation 18.185
|
-3.47 Minutes
Standard Deviation 16.754
|
-9.57 Minutes
Standard Deviation 14.483
|
-6.21 Minutes
Standard Deviation 14.140
|
-7.00 Minutes
Standard Deviation 15.727
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 5): Day 1
|
-3.36 Minutes
Standard Deviation 22.284
|
-6.16 Minutes
Standard Deviation 15.820
|
-7.53 Minutes
Standard Deviation 14.371
|
-7.44 Minutes
Standard Deviation 15.834
|
-4.34 Minutes
Standard Deviation 16.150
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 5): Day 13
|
-4.96 Minutes
Standard Deviation 22.597
|
-4.06 Minutes
Standard Deviation 20.776
|
-5.34 Minutes
Standard Deviation 20.232
|
-7.97 Minutes
Standard Deviation 17.016
|
-5.03 Minutes
Standard Deviation 16.306
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 6): Day 1
|
-1.06 Minutes
Standard Deviation 17.258
|
-4.46 Minutes
Standard Deviation 22.383
|
-5.44 Minutes
Standard Deviation 17.510
|
-7.78 Minutes
Standard Deviation 18.348
|
-1.46 Minutes
Standard Deviation 19.965
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 6): Day 13
|
-4.69 Minutes
Standard Deviation 19.658
|
-3.09 Minutes
Standard Deviation 21.426
|
0.56 Minutes
Standard Deviation 22.721
|
-7.37 Minutes
Standard Deviation 20.872
|
0.84 Minutes
Standard Deviation 20.768
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 7): Day 13
|
-3.57 Minutes
Standard Deviation 21.828
|
-4.92 Minutes
Standard Deviation 18.271
|
-1.50 Minutes
Standard Deviation 21.145
|
1.16 Minutes
Standard Deviation 23.642
|
-0.75 Minutes
Standard Deviation 18.096
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 8): Day 1
|
-7.52 Minutes
Standard Deviation 23.369
|
0.66 Minutes
Standard Deviation 21.311
|
-0.65 Minutes
Standard Deviation 22.278
|
1.25 Minutes
Standard Deviation 22.046
|
-3.95 Minutes
Standard Deviation 20.149
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 8): Day 13
|
-1.73 Minutes
Standard Deviation 24.898
|
-0.63 Minutes
Standard Deviation 20.118
|
1.88 Minutes
Standard Deviation 23.845
|
1.24 Minutes
Standard Deviation 20.858
|
-3.22 Minutes
Standard Deviation 22.343
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 1): Day 1
|
-3.40 Minutes
Standard Deviation 13.074
|
-3.55 Minutes
Standard Deviation 10.510
|
-3.44 Minutes
Standard Deviation 12.969
|
-6.37 Minutes
Standard Deviation 14.213
|
-5.40 Minutes
Standard Deviation 12.086
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 1): Day 13
|
0.43 Minutes
Standard Deviation 12.083
|
-4.78 Minutes
Standard Deviation 8.824
|
-7.05 Minutes
Standard Deviation 14.569
|
-7.47 Minutes
Standard Deviation 13.004
|
-4.90 Minutes
Standard Deviation 11.821
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 2): Day 1
|
1.06 Minutes
Standard Deviation 18.481
|
-5.72 Minutes
Standard Deviation 11.817
|
-9.62 Minutes
Standard Deviation 16.721
|
-10.82 Minutes
Standard Deviation 13.658
|
-7.68 Minutes
Standard Deviation 14.812
|
|
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
WASO (hour 2):Day 13
|
1.11 Minutes
Standard Deviation 18.504
|
-4.12 Minutes
Standard Deviation 14.596
|
-9.04 Minutes
Standard Deviation 17.034
|
-9.64 Minutes
Standard Deviation 14.963
|
-4.37 Minutes
Standard Deviation 16.883
|
SECONDARY outcome
Timeframe: Baseline, Over 6 hours on Day 1 and 13Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PSG was used to measure the number of night-time awakenings over the first 6 hours after initial sleep onset. Negative changes in nNAW indicate improvement.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13
Day 1
|
-2.08 awakenings
Standard Deviation 6.412
|
-0.87 awakenings
Standard Deviation 7.224
|
0.14 awakenings
Standard Deviation 7.385
|
-0.94 awakenings
Standard Deviation 9.102
|
-1.14 awakenings
Standard Deviation 8.727
|
|
Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13
Day 13
|
-2.02 awakenings
Standard Deviation 6.928
|
0.93 awakenings
Standard Deviation 7.769
|
-0.40 awakenings
Standard Deviation 8.352
|
-2.13 awakenings
Standard Deviation 7.542
|
-0.57 awakenings
Standard Deviation 7.803
|
SECONDARY outcome
Timeframe: Baseline, Day 1 and 13Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PSG was used to measure wake time during the total recording period. Negative changes in wake during total sleep period indicate improvement.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Wake During Total Sleep Period on Day 1 and 13
Day 1
|
-13.79 Minutes
Standard Deviation 63.082
|
-27.47 Minutes
Standard Deviation 58.188
|
-49.64 Minutes
Standard Deviation 47.106
|
-52.25 Minutes
Standard Deviation 40.828
|
-32.36 Minutes
Standard Deviation 53.737
|
|
Change From Baseline in Wake During Total Sleep Period on Day 1 and 13
Day 13
|
-18.83 Minutes
Standard Deviation 59.005
|
-19.79 Minutes
Standard Deviation 60.626
|
-42.57 Minutes
Standard Deviation 53.867
|
-41.95 Minutes
Standard Deviation 64.846
|
-20.58 Minutes
Standard Deviation 56.799
|
SECONDARY outcome
Timeframe: Baseline, Day 1 and 13Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PSG was used to measure the time awake after final awakening to the end of the PSG period. Negative changes in wake after final awakening indicate improvement.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Wake After Final Awakening on Day 1 and 13
Day 1
|
-13.63 Minutes
Standard Deviation 50.958
|
-0.28 Minutes
Standard Deviation 29.552
|
2.80 Minutes
Standard Deviation 38.492
|
7.21 Minutes
Standard Deviation 45.189
|
-5.40 Minutes
Standard Deviation 29.473
|
|
Change From Baseline in Wake After Final Awakening on Day 1 and 13
Day 13
|
-5.32 Minutes
Standard Deviation 55.112
|
-0.39 Minutes
Standard Deviation 31.519
|
12.42 Minutes
Standard Deviation 62.515
|
5.62 Minutes
Standard Deviation 48.641
|
-2.17 Minutes
Standard Deviation 29.376
|
SECONDARY outcome
Timeframe: Baseline, Day 1 and 13Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PSG was used to measure number of night time awakenings per hour. Negative changes in nNAW/hr indicate improvement.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13
Day 13
|
-0.34 Number of awakenings per hour
Standard Deviation 1.155
|
0.16 Number of awakenings per hour
Standard Deviation 1.295
|
-0.07 Number of awakenings per hour
Standard Deviation 1.392
|
-0.36 Number of awakenings per hour
Standard Deviation 1.257
|
-0.10 Number of awakenings per hour
Standard Deviation 1.300
|
|
Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13
Day 1
|
-0.35 Number of awakenings per hour
Standard Deviation 1.069
|
-0.14 Number of awakenings per hour
Standard Deviation 1.204
|
0.02 Number of awakenings per hour
Standard Deviation 1.231
|
-0.16 Number of awakenings per hour
Standard Deviation 1.517
|
-0.19 Number of awakenings per hour
Standard Deviation 1.455
|
SECONDARY outcome
Timeframe: Baseline, Day 1 and 13Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PSG was used to measure the time to first awakening after sleep onset. Positive changes in time to first awakening after sleep indicate improvement.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=70 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13
Day 1
|
12.05 Minutes
Standard Deviation 57.535
|
10.71 Minutes
Standard Deviation 61.015
|
23.11 Minutes
Standard Deviation 73.749
|
53.90 Minutes
Standard Deviation 92.802
|
35.63 Minutes
Standard Deviation 74.617
|
|
Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13
Day 13
|
11.08 Minutes
Standard Deviation 45.714
|
32.13 Minutes
Standard Deviation 70.549
|
33.12 Minutes
Standard Deviation 71.826
|
48.92 Minutes
Standard Deviation 88.909
|
27.55 Minutes
Standard Deviation 75.080
|
SECONDARY outcome
Timeframe: Baseline, Day 1 and 13Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PSG was used to measure REM duration (time to first REM period from sleep onset).
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13
Day 1
|
10.32 Minutes
Standard Deviation 24.366
|
10.23 Minutes
Standard Deviation 28.891
|
25.12 Minutes
Standard Deviation 29.495
|
23.79 Minutes
Standard Deviation 31.175
|
5.41 Minutes
Standard Deviation 22.381
|
|
Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13
Day 13
|
5.70 Minutes
Standard Deviation 29.875
|
6.40 Minutes
Standard Deviation 25.188
|
17.42 Minutes
Standard Deviation 28.699
|
12.91 Minutes
Standard Deviation 32.051
|
5.97 Minutes
Standard Deviation 28.811
|
SECONDARY outcome
Timeframe: Baseline, Day 1 and 13Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PSG was used to measure the REM latency. REM latency was defined as the time to first REM from sleep onset to reaching the first epoch of REM sleep.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=70 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=70 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=72 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13
Day 1
|
-26.60 Minute
Standard Deviation 82.487
|
-38.06 Minute
Standard Deviation 79.396
|
-85.61 Minute
Standard Deviation 84.380
|
-88.36 Minute
Standard Deviation 76.551
|
-42.73 Minute
Standard Deviation 67.024
|
|
Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13
Day 13
|
-26.41 Minute
Standard Deviation 87.903
|
-32.11 Minute
Standard Deviation 86.623
|
-83.89 Minute
Standard Deviation 83.313
|
-73.40 Minute
Standard Deviation 81.747
|
-31.59 Minute
Standard Deviation 64.953
|
SECONDARY outcome
Timeframe: Day 1 and 13Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PSG was used to measure the sleep-onset REM in participants. REM sleep periods within 15 minutes from sleep onset were measured.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13
Day 1
|
1.3 percentage of participants
|
4.2 percentage of participants
|
9.6 percentage of participants
|
14.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13
Day 13
|
1.4 percentage of participants
|
2.9 percentage of participants
|
4.1 percentage of participants
|
8.7 percentage of participants
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 and 13Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PSG was used to measure the number of sleep cycles.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Number of Sleep Cycles on Day 1 and 13
Day 1
|
0.43 sleep cycles
Standard Deviation 1.138
|
0.40 sleep cycles
Standard Deviation 1.006
|
0.97 sleep cycles
Standard Deviation 1.049
|
0.75 sleep cycles
Standard Deviation 1.155
|
0.62 sleep cycles
Standard Deviation 0.941
|
|
Change From Baseline in Number of Sleep Cycles on Day 1 and 13
Day 13
|
0.20 sleep cycles
Standard Deviation 1.222
|
0.41 sleep cycles
Standard Deviation 1.062
|
0.77 sleep cycles
Standard Deviation 1.182
|
0.45 sleep cycles
Standard Deviation 1.219
|
0.32 sleep cycles
Standard Deviation 0.955
|
SECONDARY outcome
Timeframe: Baseline, Day 1 and 13Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PSG was used to measure total time spent in non-rapid eye movement sleep stages N1, N2 and N3. Total time spent was sum of N1, N2 and N3. Positive changes in NREM duration indicate improvement.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=71 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13
Day 1
|
27.87 Minutes
Standard Deviation 68.202
|
37.62 Minutes
Standard Deviation 49.817
|
56.08 Minutes
Standard Deviation 45.218
|
57.29 Minutes
Standard Deviation 54.245
|
58.47 Minutes
Standard Deviation 52.803
|
|
Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13
Day 13
|
32.74 Minutes
Standard Deviation 61.726
|
39.33 Minutes
Standard Deviation 61.524
|
47.41 Minutes
Standard Deviation 59.791
|
51.37 Minutes
Standard Deviation 59.310
|
33.28 Minutes
Standard Deviation 62.466
|
SECONDARY outcome
Timeframe: Baseline, Days 2 and 14Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. CSD-M parameters analyzed includes: sSOL, sTST, sWASO. Negative change in sSOL, sWASO indicate improvement. Positive change in sTST indicates improvement.
Outcome measures
| Measure |
Placebo
n=71 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=66 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=68 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=69 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=68 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST)
sWASO : Day 14
|
-5.60 Minutes
Standard Deviation 55.955
|
-18.25 Minutes
Standard Deviation 56.719
|
-25.20 Minutes
Standard Deviation 58.872
|
-20.16 Minutes
Standard Deviation 65.568
|
-17.56 Minutes
Standard Deviation 51.007
|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST)
sTST: Day 2
|
-12.64 Minutes
Standard Deviation 96.051
|
4.90 Minutes
Standard Deviation 92.105
|
29.25 Minutes
Standard Deviation 67.934
|
34.50 Minutes
Standard Deviation 76.904
|
37.07 Minutes
Standard Deviation 71.297
|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST)
sSOL: Day 2
|
15.20 Minutes
Standard Deviation 61.761
|
-3.99 Minutes
Standard Deviation 46.858
|
-16.49 Minutes
Standard Deviation 42.699
|
-27.60 Minutes
Standard Deviation 34.456
|
-24.98 Minutes
Standard Deviation 30.395
|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST)
sSOL: Day 14
|
10.92 Minutes
Standard Deviation 68.201
|
-8.81 Minutes
Standard Deviation 45.936
|
-31.33 Minutes
Standard Deviation 36.888
|
-33.93 Minutes
Standard Deviation 37.274
|
-14.53 Minutes
Standard Deviation 53.705
|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST)
sWASO: Day 2
|
0.81 Minutes
Standard Deviation 75.475
|
-5.47 Minutes
Standard Deviation 61.067
|
-18.54 Minutes
Standard Deviation 51.301
|
-13.28 Minutes
Standard Deviation 48.225
|
-15.99 Minutes
Standard Deviation 84.549
|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST)
sTST: Day 14
|
3.30 Minutes
Standard Deviation 89.019
|
29.34 Minutes
Standard Deviation 83.772
|
36.79 Minutes
Standard Deviation 88.379
|
45.35 Minutes
Standard Deviation 81.983
|
27.68 Minutes
Standard Deviation 90.387
|
SECONDARY outcome
Timeframe: Baseline, Days 2 and 14Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
The CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality and how well rested participants felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality (sQUAL) and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement.
Outcome measures
| Measure |
Placebo
n=71 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=66 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=68 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=69 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=68 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
sFRESH: Day 2
|
0.07 Units on a Scale
Standard Deviation 0.930
|
0.14 Units on a Scale
Standard Deviation 0.865
|
0.34 Units on a Scale
Standard Deviation 0.852
|
0.58 Units on a Scale
Standard Deviation 1.050
|
0.41 Units on a Scale
Standard Deviation 0.876
|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
sFRESH: Day 14
|
0.26 Units on a Scale
Standard Deviation 0.826
|
0.39 Units on a Scale
Standard Deviation 1.081
|
0.51 Units on a Scale
Standard Deviation 1.005
|
0.59 Units on a Scale
Standard Deviation 1.018
|
0.41 Units on a Scale
Standard Deviation 1.051
|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
sQUAL: Day 2
|
0.11 Units on a Scale
Standard Deviation 0.995
|
0.14 Units on a Scale
Standard Deviation 1.054
|
0.49 Units on a Scale
Standard Deviation 0.896
|
0.49 Units on a Scale
Standard Deviation 1.091
|
0.66 Units on a Scale
Standard Deviation 0.818
|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
sQUAL: Day 14
|
0.26 Units on a Scale
Standard Deviation 1.024
|
0.43 Units on a Scale
Standard Deviation 1.172
|
0.79 Units on a Scale
Standard Deviation 1.189
|
0.67 Units on a Scale
Standard Deviation 1.159
|
0.52 Units on a Scale
Standard Deviation 1.084
|
SECONDARY outcome
Timeframe: Baseline, Days 2 and 14Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. CSD-M parameters analyzed include: s-nNAW. Negative change in s-nNAW indicate improvement.
Outcome measures
| Measure |
Placebo
n=71 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=66 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=68 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=69 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=68 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW)
Day 14
|
0.10 awakenings
Standard Deviation 1.234
|
0.04 awakenings
Standard Deviation 1.580
|
0.05 awakenings
Standard Deviation 1.320
|
-0.02 awakenings
Standard Deviation 1.175
|
-0.22 awakenings
Standard Deviation 1.376
|
|
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW)
Day 2
|
0.64 awakenings
Standard Deviation 2.197
|
0.21 awakenings
Standard Deviation 1.465
|
0.49 awakenings
Standard Deviation 1.465
|
0.27 awakenings
Standard Deviation 1.418
|
0.38 awakenings
Standard Deviation 6.076
|
SECONDARY outcome
Timeframe: Baseline, Days 8 and 14Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PROMIS Sleep Disturbance (PROMIS-SD) Short Form subscale consists of a static 8-item questionnaire. Using a recall period of the past 7 days, it assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Each question has 5 response options ranging in value from 1 to 5. To find the total raw score for a short form with all questions answered, sum the values of the response to each question and a total score ranges from 8 to 40. Lower scores indicate less sleep disturbance. Negative changes in scores indicate improvement.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=60 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=66 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=63 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=66 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14
Day 8
|
-4.9 Unit on a Scale
Standard Deviation 6.81
|
-9.0 Unit on a Scale
Standard Deviation 7.13
|
-9.2 Unit on a Scale
Standard Deviation 7.17
|
-9.6 Unit on a Scale
Standard Deviation 8.16
|
-8.3 Unit on a Scale
Standard Deviation 7.31
|
|
Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14
Day 14
|
-5.7 Unit on a Scale
Standard Deviation 7.75
|
-10.8 Unit on a Scale
Standard Deviation 7.64
|
-10.3 Unit on a Scale
Standard Deviation 7.39
|
-9.5 Unit on a Scale
Standard Deviation 7.93
|
-10.1 Unit on a Scale
Standard Deviation 8.06
|
SECONDARY outcome
Timeframe: Baseline, Days 8 and 14Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
PROMIS-Sleep Related Impairment (PROMIS-SRI) scale consists of 8 items to evaluate daytime consequences of functioning 5-point Likert scale ranging from 1 to 5. PROMIS-SRI measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Each question has five response options ranging in value from 1 to 5. To find total raw score (which range from 8 to 40) with all questions answered, sum values of response to each question. Higher score indicates greater sleep impairment.
Outcome measures
| Measure |
Placebo
n=61 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=59 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=63 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=62 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=65 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14
Day 8
|
-4.0 Units on a Scale
Standard Deviation 6.56
|
-7.0 Units on a Scale
Standard Deviation 6.15
|
-5.5 Units on a Scale
Standard Deviation 6.55
|
-8.8 Units on a Scale
Standard Deviation 7.09
|
-4.9 Units on a Scale
Standard Deviation 6.98
|
|
Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14
Day 14
|
-5.2 Units on a Scale
Standard Deviation 6.88
|
-9.1 Units on a Scale
Standard Deviation 6.53
|
-6.3 Units on a Scale
Standard Deviation 6.94
|
-7.8 Units on a Scale
Standard Deviation 6.98
|
-7.4 Units on a Scale
Standard Deviation 6.35
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
The PGI-S is a self-reported scale to measure severity of illness using a 6-point scale ranging from 1 to 6, (1=no insomnia, 2=very mild, 3=mild, 4=moderate, 5=severe, 6=very severe). Considering all aspects of insomnia, participants rated their severity on the PGI-S scale. Negative changes in scores indicate improvement.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=59 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=65 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=62 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=65 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale Score on Day 14
|
0.00 Unit on a Scale
Full Range -5.0 • Interval -5.0 to 2.0
|
-1.00 Unit on a Scale
Full Range -4.0 • Interval -4.0 to 2.0
|
-1.00 Unit on a Scale
Full Range -4.0 • Interval -4.0 to 1.0
|
-1.00 Unit on a Scale
Full Range -5.0 • Interval -5.0 to 1.0
|
-1.00 Unit on a Scale
Full Range -4.0 • Interval -4.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
PGI-I is a self-reported scale to measure improvement in illness using a 7-point scale ranging from 1 to 7, (1=very much improved, 2=much improved, 3=improved \[just enough to make a difference\], 4=no change, 5=worse \[just enough to make a difference\], 6=much worse, 7=very much worse). Negative changes in scores indicate improvement.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=62 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=69 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=65 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=67 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale Score on Day 14
|
3.00 Units on a Scale
Full Range 0.0 • Interval 0.0 to 5.0
|
2.00 Units on a Scale
Full Range 0.0 • Interval 0.0 to 5.0
|
2.00 Units on a Scale
Full Range 0.0 • Interval 0.0 to 4.0
|
2.00 Units on a Scale
Full Range 0.0 • Interval 0.0 to 4.0
|
2.00 Units on a Scale
Full Range 0.0 • Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 14Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number participants evaluable for this outcome measure. Participants with missing values at a given time point were excluded from frequency calculation for that time point.
Percentage of participants who achieved at least 50% reduction from baseline in ISI total score (responders) were reported. It is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems; distress caused by sleep difficulties. 5-point Likert scale (0-4) was used to rate each item, Scores are summed for a total score which ranges from 0-28. Negative changes in scores indicate improvement. ISI total score is the sum of all item scores. Total score interpreted insomnia as follows: absence (0-7); sub-threshold (8-14); moderate (15-21); severe (22-28).
Outcome measures
| Measure |
Placebo
n=69 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=69 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=69 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=70 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Response Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case
|
23.2 percentage of participants
|
42.0 percentage of participants
|
31.5 percentage of participants
|
34.8 percentage of participants
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 14Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Participants with missing values at a given time point are excluded from the frequency calculation for that time point.
Percentage of participants with remission of insomnia symptom defined as, total score of \<= 10 on ISI scale. ISI is 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; distress caused by sleep difficulties. 5-point Likert scale (0-4) is used to rate each item. ISI total score is the sum of all item scores. ISI total score is the sum of all item scores. Scores are summed for a total score which ranges from 0-28 and interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); severe insomnia (22-28).
Outcome measures
| Measure |
Placebo
n=69 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=69 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=69 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=70 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Remission Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case
|
24.6 percentage of participants
|
43.5 percentage of participants
|
37.0 percentage of participants
|
39.1 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
The CGI-S is a 7-point scale to measure severity of illness (1=normal \[not at all ill\], 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants). Higher score indicates more severity. Negative changes in scores indicate improvement.
Outcome measures
| Measure |
Placebo
n=69 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=69 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=69 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=70 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Score on Day 14
|
0.0 Units on a scale
Interval -5.0 to 1.0
|
-1.0 Units on a scale
Interval -5.0 to 3.0
|
-1.0 Units on a scale
Interval -5.0 to 2.0
|
-1.0 Units on a scale
Interval -5.0 to 1.0
|
-1.0 Units on a scale
Interval -5.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
The CGI-I is a 7-point scale to measure improvement in illness using a 7-point scale ranging from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change from baseline, 5=minimally worse, 6=much worse, 7=very much worse). Higher score indicates more severity. Negative changes in scores indicate improvement.
Outcome measures
| Measure |
Placebo
n=69 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=69 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=69 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=70 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Score on Day 14
|
3.0 Units on a Scale
Interval 1.0 to 5.0
|
3.0 Units on a Scale
Interval 1.0 to 5.0
|
3.0 Units on a Scale
Interval 1.0 to 4.0
|
3.0 Units on a Scale
Interval 1.0 to 5.0
|
2.0 Units on a Scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Up to Day 17Population: Safety analysis set (SAS) included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent adverse events are adverse events with an onset date occurring at or after the initial administration of study drug through the Day 17 telephone contact date, or the day of last dose plus 3 days for participants without the Day 17 telephone contact date.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=72 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
|
37 Participants
|
29 Participants
|
23 Participants
|
21 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Up to Day 17Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
Treatment-emergent serious adverse events are serious adverse events with an onset date occurring at or after the initial administration of study drug through the Day 17 telephone contact date, or the day of last dose plus 3 days for participants without the Day 17 telephone contact date. Events of special interest included: Cataplexy; Sleep paralysis; Complex sleep-related behaviors such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (REM-associated end-inspiratory apnea/breath holding); Abnormal dreams; Falls.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=72 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest
Treatment-emergent Serious AE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest
Events of Special Interest
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Day 15Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses. Here, 'n' (number analyzed) signifies number of participants who were evaluable for specified categories.
Clinically significant vital signs (pulse, supine and standing blood pressure (systolic and diastolic), and oral, temperature) and physical abnormalities (body weight) were reported. Abnormally low parameters included pulse (bpm)- decrease value from baseline greater than or equal to (\>=) 15 to \<=50; Systolic BP (mmHg \[Millimeter of mercury\])- decrease value from baseline \>=20 to \<=90; Diastolic BP- decrease value from baseline \>=15 to \<=50; weight (Kilogram\[Kg\])- decrease from baseline \>=7%; Body temperature (Celsius \[C\])- \<35.5. Abnormally high parameters included pulse- increase value from baseline \>=15 to \>=100; Systolic BP(mmHg)- increase from baseline of \>=20 to \>=180; Diastolic BP- increase value from baseline \>=15 to \>=105; weight(Kg)- increase from baseline of \>=7%; body temperature (C)- \>37.5.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=72 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Supine Pulse Rate: Abnormally low
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Supine Pulse Rate: Abnormally high
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Standing Pulse Rate: Abnormally low
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Standing Pulse Rate: Abnormally high
|
8 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Supine Systolic BP: Abnormally low
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Supine Systolic BP: Abnormally high
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Standing Systolic BP: Abnormally low
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Standing Systolic BP: Abnormally high
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Supine Diastolic BP: Abnormally low
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Supine Diastolic BP: Abnormally high
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Standing Diastolic BP: Abnormally low
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Standing Diastolic BP: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Temperature: Abnormally low
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Temperature: Abnormally high
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Weight: Abnormally low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Weight: Abnormally high
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable for specified categories.
Twelve-lead ECGs were recorded in a supine position and different ECG intervals (Respiratory rate \[RR\], PR, time for ventricular depolarization \[QRS\], and total time from ventricular depolarization to complete repolarization \[QT\]) and heart rate was measured. This included heart rate:\<=50 beats per minute (bpm) and \>=100 bpm; PR interval \<=120 millisecond (msec) and \>=200 msec; QRS interval: \<=60 msec and \>=120 msec; QT interval:\<=200 msec and \>=500 msec.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=70 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=71 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=68 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=71 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Heart rate: <=50 bpm
|
10 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Heart rate:>=100 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
PR interval: <=120 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
PR interval: >=200 msec
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QRS interval: <=60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QRS interval: >=120 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QT interval: <=200 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QT interval: >=500 msec
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 15Population: Analysis population was SAS. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here,'n' (number analyzed) signifies number of participants who were evaluable for specified categories. 1 participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922.This participant was summarized under the 5 mg dose group for safety analyses.
Number of participants with clinically significant laboratory abnormalities were reported. Blood samples for serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, chloride, creatine Kinase, gamma glutamyl transferase, lactate dehydrogenase, phosphate, potassium, sodium), and urinalysis (bilirubin, protein) were collected for clinical laboratory testing.
Outcome measures
| Measure |
Placebo
n=69 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=70 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=71 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=68 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=71 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Alanine Aminotransferase: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Albumin: Abnormally low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Albumin: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Alkaline Phosphatase: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Aspartate Aminotransferase: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Bicarbonate: Abnormally low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Bicarbonate: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Bilirubin: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Calcium: Abnormally low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Calcium: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chloride: Abnormally low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Chloride: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Creatine Kinase: Abnormally high
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Creatinine: Abnormally high
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Direct Bilirubin: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Gamma Glutamyl Transferase: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Lactate Dehydrogenase: Abnormally high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Phosphate: Abnormally low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Phosphate: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Potassium: Abnormally low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Potassium: Abnormally high
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Protein: Abnormally low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Sodium: Abnormally low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Sodium: Abnormally high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: SAS included all participants who were randomly assigned to drug and received at least 1 dose of drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. 1 participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922 and was summarized under 5 mg dose group for safety analyses.
C-SSRS is a questionnaire designed to solicit occurrence, severity, frequency of suicidal ideation/behaviors using following scores: Suicidal Ideation-1:Wish to be Dead; 2:Non-specific Active Suicidal Thoughts; 3:Active Suicidal Ideation with Any Methods without Intent to Act; 4:Active Suicidal Ideation with Some Intent to Act; 5:Active Suicidal Ideation with Specific Plan/Intent; Suicidal Behavior-6:Preparatory Acts; 7:Aborted Attempt; 8:Interrupted Attempt; 9:Actual Attempt; 10:Completed Suicide. If no events qualify for score of 1-10, score 0 indicate "no event that can be assessed on basis of C-SSRS". Higher scores= greater severity.
Outcome measures
| Measure |
Placebo
n=69 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=70 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=72 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=69 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=70 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 0: No Event
|
69 Participants
|
70 Participants
|
72 Participants
|
69 Participants
|
70 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 10: Completed Suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 1: Wish to be Dead
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 2: Non-Specific Active Suicidal Thoughts
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 3: Suicidal Ideation Without Plan and Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 4: Suicidal Ideation Intent to Act Without Plan
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 5: Suicidal Ideation With Plan and Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 6: Preparatory Acts or Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 7: Aborted Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 8: Interrupted Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Score 9: Actual Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Days 2 and 14Population: Analysis population was SAS. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a single item assessed on 9-point Likert scale with response options from: 1=very alert to 9=very sleepy (fighting sleep). Negative changes indicate improvement.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=62 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=65 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=59 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=67 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14
Day 2
|
0.3 Units on a Scale
Standard Deviation 1.75
|
-0.4 Units on a Scale
Standard Deviation 1.86
|
-0.2 Units on a Scale
Standard Deviation 1.42
|
-0.5 Units on a Scale
Standard Deviation 1.86
|
-0.4 Units on a Scale
Standard Deviation 1.68
|
|
Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14
Day 14
|
0.1 Units on a Scale
Standard Deviation 1.82
|
-0.8 Units on a Scale
Standard Deviation 2.15
|
-0.6 Units on a Scale
Standard Deviation 1.72
|
-0.7 Units on a Scale
Standard Deviation 1.90
|
-0.7 Units on a Scale
Standard Deviation 2.01
|
SECONDARY outcome
Timeframe: Day 14 (morning)Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. Body sway was measured using an ataxiameter. Participants were instructed to wear a pair of thin socks for each session. Before starting a measurement, participants were asked to stand still and comfortable, with their feet approximately 10 centimeters (cm) apart and their hands in a relaxed position alongside the body and eyes closed. The total period of body sway measurement was 2 minutes.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=66 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=69 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=67 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=69 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Postural Stability Measured by Ataxiameter
|
-0.06 1/3 Degree Angle of Arc
Standard Deviation 17.15
|
3.14 1/3 Degree Angle of Arc
Standard Deviation 16.14
|
-0.87 1/3 Degree Angle of Arc
Standard Deviation 15.62
|
-0.25 1/3 Degree Angle of Arc
Standard Deviation 14.71
|
1.65 1/3 Degree Angle of Arc
Standard Deviation 14.11
|
SECONDARY outcome
Timeframe: Baseline and Day 14 (Morning)Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
Power of Attention is a combination of the speed scores from the three tests of attention, and is established to reflect the ability to focus attention and to process information. Power of Attention was calculated from the sum of the reaction time measured from the attentional tasks (Simple Reaction Time, Choice Reaction Time and Digit Vigilance Speed). Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration.
Outcome measures
| Measure |
Placebo
n=67 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=66 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=68 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=67 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=69 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
|
35.88 milliseconds (ms)
Standard Deviation 125.43
|
48.59 milliseconds (ms)
Standard Deviation 137.75
|
67.09 milliseconds (ms)
Standard Deviation 257.67
|
37.07 milliseconds (ms)
Standard Deviation 124.23
|
35.38 milliseconds (ms)
Standard Deviation 189.99
|
SECONDARY outcome
Timeframe: Baseline and Day 14 (Morning)Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.
Outcome measures
| Measure |
Placebo
n=67 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=66 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=68 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=67 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=69 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
|
0.36 units on a scale
Standard Deviation 5.31
|
-0.20 units on a scale
Standard Deviation 3.16
|
-1.37 units on a scale
Standard Deviation 6.35
|
0.10 units on a scale
Standard Deviation 5.05
|
-0.39 units on a scale
Standard Deviation 5.14
|
SECONDARY outcome
Timeframe: Baseline and Day 14 (Morning)Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
Quality of working memory is a combination of the scores from Spatial Working Memory and Numeric Working Memory tasks, and is established to reflect the ability to temporarily hold numeric and spatial information in memory. Sum of Spatial and Numeric Working Memory sensitivity indices (SI) (accuracy) was used to calculate the quality of working memory. The quality of working memory score was calculated from formulae that combined the accuracy scores for the original as well as the new (distractor) stimuli. The range for both the numeric working memory and spatial working memory tasks SI are -1 to 1. Smaller scores reflect poorer ability (poorer quality of working memory),larger scores reflect better ability (better quality of working memory). Total score is the sum of Spatial Working Memory and Numeric Working Memory (ranges from -2 to 2). Smaller scores reflect poorer ability (poorer quality of working memory), larger scores reflect better ability (better quality of working memory.
Outcome measures
| Measure |
Placebo
n=67 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=65 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=68 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=67 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=69 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
|
0.00 Units on scale
Standard Deviation 0.35
|
-0.03 Units on scale
Standard Deviation 0.28
|
-0.02 Units on scale
Standard Deviation 0.41
|
-0.04 Units on scale
Standard Deviation 0.29
|
0.05 Units on scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Baseline and Day 14 (Morning)Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant is summarized under the 5 mg dose group. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (that is an event or a name) and a negative change from baseline reflects impairment compared to baseline.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=65 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=68 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=66 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=67 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
|
-22.84 units on scale
Standard Deviation 53.73
|
-23.15 units on scale
Standard Deviation 46.02
|
-33.58 units on scale
Standard Deviation 48.82
|
-25.45 units on scale
Standard Deviation 56.37
|
-37.96 units on scale
Standard Deviation 55.94
|
SECONDARY outcome
Timeframe: Baseline and Day 14 (Morning)Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
The sum of the speed measures from the two working memory tasks (Spatial and Numeric) and the two recognition tasks (Word and Picture). Speed of Memory combines reaction times from Spatial Working Memory (range:150 to 30000 millisecond \[ms\]), Numeric Working Memory (150 to 30000 ms), Word Recognition (250 to 30000 ms) and Picture recognition (250 to 30000 ms) tasks. The total reaction time (sum of above 4 reaction times) measures memory retrieval speed which ranges from 800 to 120000 ms. Slower reaction time reflect poorer ability and faster reaction time reflect better ability.
Outcome measures
| Measure |
Placebo
n=67 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=65 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=68 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=67 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=69 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
|
-104.75 millisecond
Standard Deviation 787.74
|
258.38 millisecond
Standard Deviation 719.56
|
7.57 millisecond
Standard Deviation 806.27
|
-65.67 millisecond
Standard Deviation 761.77
|
-83.70 millisecond
Standard Deviation 1060.38
|
SECONDARY outcome
Timeframe: Day 14 to Day 17Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable for specified categories.
CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. Negative change in sSOL, sWASO indicate improvement and positive change in Subjective Total Sleep Time (sTST) indicates improvement.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=58 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=57 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=56 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=58 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST
sWASO
|
-12.39 Minutes
Standard Deviation 57.711
|
-0.76 Minutes
Standard Deviation 66.663
|
-2.13 Minutes
Standard Deviation 41.505
|
-10.80 Minutes
Standard Deviation 63.672
|
3.76 Minutes
Standard Deviation 58.805
|
|
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST
sSOL
|
-20.56 Minutes
Standard Deviation 74.145
|
-4.83 Minutes
Standard Deviation 43.769
|
9.67 Minutes
Standard Deviation 29.798
|
15.55 Minutes
Standard Deviation 32.327
|
9.57 Minutes
Standard Deviation 72.253
|
|
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST
sTST
|
30.95 Minutes
Standard Deviation 101.367
|
13.07 Minutes
Standard Deviation 102.093
|
6.96 Minutes
Standard Deviation 96.664
|
19.71 Minutes
Standard Deviation 66.447
|
-7.95 Minutes
Standard Deviation 102.183
|
SECONDARY outcome
Timeframe: Day 14 to Day 17Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality (sQUAL) and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=58 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=57 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=56 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=58 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
sFRESH
|
0.13 Units on a Scale
Standard Deviation 1.085 • Interval 1.085 to
|
0.17 Units on a Scale
Standard Deviation 1.011 • Interval 1.011 to
|
0.04 Units on a Scale
Standard Deviation 1.017 • Interval 1.017 to
|
0.11 Units on a Scale
Standard Deviation 1.073 • Interval 1.073 to
|
-0.03 Units on a Scale
Standard Deviation 0.898 • Interval 0.898 to
|
|
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
sQUAL
|
0.19 Units on a Scale
Standard Deviation 1.242 • Interval 1.242 to
|
0.24 Units on a Scale
Standard Deviation 1.129 • Interval 1.129 to
|
-0.07 Units on a Scale
Standard Deviation 1.083 • Interval 1.083 to
|
0.02 Units on a Scale
Standard Deviation 1.120 • Interval 1.12 to
|
-0.12 Units on a Scale
Standard Deviation 1.010 • Interval 1.01 to
|
SECONDARY outcome
Timeframe: Day 14 to Day 17Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: s-nNAW. Negative change in s-nNAW indicate improvement.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=58 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=57 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=56 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=58 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW)
|
0.16 awakenings
Standard Deviation 3.525 • Interval 3.525 to
|
-0.59 awakenings
Standard Deviation 2.009 • Interval 2.009 to
|
-0.35 awakenings
Standard Deviation 1.217 • Interval 1.217 to
|
-0.36 awakenings
Standard Deviation 1.052 • Interval 1.052 to
|
-0.34 awakenings
Standard Deviation 1.396 • Interval 1.396 to
|
SECONDARY outcome
Timeframe: Day 14 to Day 17Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. 1 participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922 and was summarized under 5 mg dose group for safety analyses.
PWC-20 is a reliable, sensitive instrument having 20-items used to assess potential withdrawal symptoms following cessation of treatment. Items are as follows: Loss of Appetite, Nausea-Vomiting, Diarrhea, Anxiety-Nervousness, Irritability, Dysphoric Mood-Depression, Insomnia, Fatigue, Poor Coordination, Restlessness, Diaphoresis, Tremor, Dizziness, Headaches, Stiffness, Weakness, Increased Acuity Sound Smell Touch (IASST), Paresthesias, Remember, Derealization. Each item score ranges from 0 (not present)-3 (severe), where higher scores = more affected condition. Total score ranges from 0-60, where higher score indicates more affected condition. PWC-20 score was imputed as follows: sum of the non-missing items \* (total number of items) / (number of items non-missing).
Outcome measures
| Measure |
Placebo
n=69 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=69 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=70 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=68 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=69 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Paresthesias:Symptoms Present and Unchanged
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
IASST: Improved Symptoms
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
IASST: Symptoms Present and Unchanged
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
IASST: New or Worsened Symptoms
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Paresthesias:Improved Symptoms
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Paresthesias:No Symptoms
|
62 Participants
|
68 Participants
|
66 Participants
|
68 Participants
|
68 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Paresthesias:New or Worsened Symptoms
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Weakness:Improved Symptoms
|
3 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Headaches:No Symptoms
|
56 Participants
|
51 Participants
|
61 Participants
|
60 Participants
|
56 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Headaches:Improved Symptoms
|
9 Participants
|
12 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Headaches:Symptoms Present and Unchanged
|
2 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Headaches:New or Worsened Symptoms
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Stiffness:No Symptoms
|
59 Participants
|
62 Participants
|
64 Participants
|
63 Participants
|
59 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Stiffness:Improved Symptoms
|
8 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Stiffness:Symptoms Present and Unchanged
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Stiffness:New or Worsened Symptoms
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Weakness:No Symptoms
|
61 Participants
|
69 Participants
|
65 Participants
|
65 Participants
|
65 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Weakness:Symptoms Present and Unchanged
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Weakness:New or Worsened Symptoms
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
IASST: No Symptoms
|
64 Participants
|
66 Participants
|
66 Participants
|
63 Participants
|
62 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Loss of Appetite: No Symptoms
|
65 Participants
|
69 Participants
|
65 Participants
|
68 Participants
|
66 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Loss of Appetite: Improved Symptoms
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Loss of Appetite: Symptoms Present and Unchanged
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Loss of Appetite: New or Worsened Symptoms
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Nausea-Vomiting: No Symptoms
|
67 Participants
|
67 Participants
|
66 Participants
|
67 Participants
|
63 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Nausea-Vomiting: Improved Symptoms
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Nausea-Vomiting: Symptoms Present and Unchanged
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Nausea-Vomiting: New or Worsened Symptoms
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Diarrhea: No Symptoms
|
65 Participants
|
69 Participants
|
67 Participants
|
67 Participants
|
63 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Diarrhea: Improved Symptoms
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Diarrhea: Symptoms Present and Unchanged
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Diarrhea: New or Worsened Symptoms
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Anxiety-Nervousness: No Symptoms
|
64 Participants
|
68 Participants
|
64 Participants
|
62 Participants
|
62 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Anxiety-Nervousness:Improved Symptoms
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Anxiety-Nervousness:Symptoms Present and Unchanged
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Anxiety-Nervousness: New or Worsened Symptoms
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Irritability: No Symptoms
|
58 Participants
|
58 Participants
|
59 Participants
|
60 Participants
|
58 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Irritability:Improved Symptoms
|
6 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Irritability:Symptoms Present and Unchanged
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Irritability:New or Worsened Symptoms
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Dysphoric Mood: No Symptoms
|
66 Participants
|
66 Participants
|
68 Participants
|
65 Participants
|
66 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Dysphoric Mood: Improved Symptoms
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Dysphoric Mood: Symptoms Present and Unchanged
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Dysphoric Mood: New or Worsened Symptoms
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Insomnia: No Symptoms
|
12 Participants
|
14 Participants
|
11 Participants
|
17 Participants
|
16 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Insomnia: Improved Symptoms
|
19 Participants
|
15 Participants
|
13 Participants
|
11 Participants
|
15 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Insomnia: Symptoms Present and Unchanged
|
27 Participants
|
28 Participants
|
32 Participants
|
28 Participants
|
21 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Insomnia: New or Worsened Symptoms
|
11 Participants
|
12 Participants
|
14 Participants
|
12 Participants
|
17 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Fatigue: No Symptoms
|
30 Participants
|
43 Participants
|
41 Participants
|
45 Participants
|
44 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Fatigue: Improved Symptoms
|
21 Participants
|
15 Participants
|
19 Participants
|
8 Participants
|
14 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Fatigue: Symptoms Present and Unchanged
|
5 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Fatigue: New or Worsened Symptoms
|
13 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Poor Coordination: No Symptoms
|
61 Participants
|
65 Participants
|
63 Participants
|
61 Participants
|
61 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Poor Coordination: Improved Symptoms
|
6 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Poor Coordination: Symptoms Present and Unchanged
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Poor Coordination: New/Worsened Symptoms
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Restlessness:No Symptoms
|
55 Participants
|
59 Participants
|
59 Participants
|
60 Participants
|
60 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Restlessness:Improved Symptoms
|
9 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Restlessness:Symptoms Present and Unchanged
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Restlessness:New or Worsened Symptoms
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Diaphoresis:No Symptoms
|
64 Participants
|
68 Participants
|
65 Participants
|
65 Participants
|
64 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Diaphoresis:Improved Symptoms
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Diaphoresis:Symptoms Present and Unchanged
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Diaphoresis:New or Worsened Symptoms
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Tremor: No Symptoms
|
66 Participants
|
68 Participants
|
69 Participants
|
68 Participants
|
67 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Tremor: Improved Symptoms
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Tremor: Symptoms Present and Unchanged
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Tremor: New or Worsened Symptoms
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Dizziness:No Symptoms
|
63 Participants
|
69 Participants
|
66 Participants
|
64 Participants
|
60 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Dizziness: Improved Symptoms
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Dizziness: Symptoms Present and Unchanged
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Dizziness:New or Worsened Symptoms
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Remember:No Symptoms
|
50 Participants
|
60 Participants
|
56 Participants
|
56 Participants
|
53 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Remember:Improved Symptoms
|
9 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Remember:Symptoms Present and Unchanged
|
5 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Remember:New or Worsened Symptoms
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Derealization:No Symptoms
|
64 Participants
|
68 Participants
|
68 Participants
|
67 Participants
|
68 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Derealization:Improved Symptoms
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Derealization:Symptoms Present and Unchanged
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Derealization:New or Worsened Symptoms
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 17Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participant analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
The BWSQ is a 20 symptom self-reported questionnaire to investigate withdrawal symptoms. Total score is the sum of item scores. Total scores can range from 0-40 with higher scores indicating greater severity of symptoms. Participants rated the degree to which they were experiencing each symptom as either "0=No," "1=Yes-moderate" or "2=Yes-severe". The questionnaire had been shown to be reliable and to have acceptable construct validity in assessing withdrawal symptoms.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=54 Participants
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=56 Participants
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=51 Participants
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=55 Participants
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17
|
1.5 Units on a Scale
Standard Deviation 2.58
|
1.2 Units on a Scale
Standard Deviation 1.90
|
2.0 Units on a Scale
Standard Deviation 3.44
|
1.5 Units on a Scale
Standard Deviation 2.93
|
2.0 Units on a Scale
Standard Deviation 3.10
|
Adverse Events
Placebo
JNJ-42847922 5 mg
JNJ-42847922 10 mg
JNJ-42847922 20 mg
Zolpidem
Serious adverse events
| Measure |
Placebo
n=75 participants at risk
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=72 participants at risk
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 participants at risk
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 participants at risk
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 participants at risk
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/75 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/72 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/73 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/71 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/73 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/75 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/72 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/73 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/71 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/73 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
Other adverse events
| Measure |
Placebo
n=75 participants at risk
Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 5 mg
n=72 participants at risk
Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 10 mg
n=73 participants at risk
Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
JNJ-42847922 20 mg
n=71 participants at risk
Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
|
Zolpidem
n=73 participants at risk
Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
1.3%
1/75 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/72 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/73 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
5.6%
4/71 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
5.5%
4/73 • Number of events 5 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
3/75 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/72 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/73 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/71 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
5.5%
4/73 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
2/75 • Number of events 2 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/72 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
2.7%
2/73 • Number of events 2 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/71 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
6.8%
5/73 • Number of events 5 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
General disorders
Fatigue
|
10.7%
8/75 • Number of events 8 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
5.6%
4/72 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
4.1%
3/73 • Number of events 3 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
2.8%
2/71 • Number of events 2 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
2.7%
2/73 • Number of events 2 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/75 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
5.6%
4/72 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/73 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/71 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/73 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
Infections and infestations
Urinary Tract Infection
|
5.3%
4/75 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/72 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/73 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/71 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/73 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
3/75 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/72 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/73 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/71 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
5.5%
4/73 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
Nervous system disorders
Disturbance in Attention
|
5.3%
4/75 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
2.8%
2/72 • Number of events 2 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/73 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/71 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
5.5%
4/73 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
Nervous system disorders
Dizziness
|
1.3%
1/75 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/72 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/73 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/71 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
6.8%
5/73 • Number of events 7 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
Nervous system disorders
Headache
|
10.7%
8/75 • Number of events 8 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
9.7%
7/72 • Number of events 8 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
5.5%
4/73 • Number of events 6 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
8.5%
6/71 • Number of events 8 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
11.0%
8/73 • Number of events 10 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
|
Psychiatric disorders
Restlessness
|
5.3%
4/75 • Number of events 4 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
0.00%
0/72 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
2.7%
2/73 • Number of events 2 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
2.8%
2/71 • Number of events 2 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
1.4%
1/73 • Number of events 1 • Up to Day 17
Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
|
Additional Information
Senior Director Clinical Development
Janssen Research & Development, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER