Trial · NCT03375203
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
NCT03375203, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2022-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder. Trials, record NCT03375203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03375203
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
- NCT number
- NCT03375203
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 365 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Insomnia Disorders
- Interventions
- Placebo, JNJ-42847922, 5 mg, JNJ-42847922, 10 mg, JNJ-42847922, 20 mg, Zolpidem
- First posted
- 2017-12-15
- Last updated
- 2025-04-29
- Other registries' IDs
- eudract:2017-000980-33
- Results first posted
- 2022-05-23
Source ClinicalTrials.gov
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | Baseline and Night 1 | 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. |
| Secondary | Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | Baseline and over first 6 hours on Night 1 | 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. |
| Secondary | Change From Baseline in LPS as Measured by PSG on Night 13 | Baseline and Night 13 | 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. |
| Secondary | Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 | Baseline and over first 6 hours on Night 13 | 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. |
| Secondary | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Baseline, Over 6 hours on Nights 1 and 13 | 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. |
| Secondary | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Baseline, Over 8 hours on Nights 1 and 13 | 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. |
| Secondary | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Baseline, Nights 1 and 13 | 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. |
| Secondary | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | Baseline, Days 1 and 13 (Hours 1 to 8) | 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. |
| Secondary | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Baseline, Over 6 hours on Day 1 and 13 | 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. |
| Secondary | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure wake time during the total recording period. Negative changes in wake during total sleep period indicate improvement. |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 registered outcomesOutcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | Baseline and Night 1 | 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. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | Baseline and over first 6 hours on Night 1 | 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. | Minutes | MEAN |
| SECONDARY | Change From Baseline in LPS as Measured by PSG on Night 13 | Baseline and Night 13 | 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. | Minutes | MEAN |
| SECONDARY | Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 | Baseline and over first 6 hours on Night 13 | 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. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Baseline, Over 6 hours on Nights 1 and 13 | 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. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Baseline, Over 8 hours on Nights 1 and 13 | 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. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Baseline, Nights 1 and 13 | 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. | Percentage of efficient sleep | MEAN |
| SECONDARY | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | Baseline, Days 1 and 13 (Hours 1 to 8) | 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. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Baseline, Over 6 hours on Day 1 and 13 | 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. | awakenings | MEAN |
| SECONDARY | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Baseline, Day 1 and 13 | 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. | Minutes | MEAN |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 outcomesResults by group1,125
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | Placebo | -15.24 | Standard Deviation 78.547 | Minutes | |
| Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | JNJ-42847922 5 mg | -29.92 | Standard Deviation 49.049 | Minutes | |
| Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | JNJ-42847922 10 mg | -49.49 | Standard Deviation 53.216 | Minutes | |
| Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | JNJ-42847922 20 mg | -47.69 | Standard Deviation 48.423 | Minutes | |
| Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | Zolpidem | -40.74 | Standard Deviation 54.395 | Minutes | |
| Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | Placebo | -15.05 | Standard Deviation 57.485 | Minutes | |
| Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | JNJ-42847922 5 mg | -22.70 | Standard Deviation 45.904 | Minutes | |
| Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | JNJ-42847922 10 mg | -42.57 | Standard Deviation 40.011 | Minutes | |
| Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | JNJ-42847922 20 mg | -44.69 | Standard Deviation 42.823 | Minutes | |
| Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | Zolpidem | -29.04 | Standard Deviation 46.779 | Minutes |
1 to 10 of 1,125Source ClinicalTrials.gov
See all 1,125 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 75 | |
| Overall Study | STARTED | JNJ-42847922 5 mg | 72 | |
| Overall Study | STARTED | JNJ-42847922 10 mg | 74 | |
| Overall Study | STARTED | JNJ-42847922 20 mg | 71 | |
| Overall Study | STARTED | Zolpidem | 73 | |
| Overall Study | COMPLETED | Placebo | 69 | |
| Overall Study | COMPLETED | JNJ-42847922 5 mg | 68 | |
| Overall Study | COMPLETED | JNJ-42847922 10 mg | 72 | |
| Overall Study | COMPLETED | JNJ-42847922 20 mg | 69 | |
| Overall Study | COMPLETED | Zolpidem | 69 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events65
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 75 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | JNJ-42847922 5 mg | 0 | 72 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | JNJ-42847922 10 mg | 0 | 73 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | JNJ-42847922 20 mg | 1 | 71 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Zolpidem | 4 | 73 | 4 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 75 | 2 |
| other | Nausea | Gastrointestinal disorders | JNJ-42847922 5 mg | 1 | 72 | 1 |
| other | Nausea | Gastrointestinal disorders | JNJ-42847922 10 mg | 2 | 73 | 2 |
| other | Nausea | Gastrointestinal disorders | JNJ-42847922 20 mg | 0 | 71 | 0 |
| other | Nausea | Gastrointestinal disorders | Zolpidem | 5 | 73 | 5 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 75 |
| Total, all-cause mortality | JNJ-42847922 5 mg | 0 | 72 |
| Total, all-cause mortality | JNJ-42847922 10 mg | 0 | 73 |
| Total, all-cause mortality | JNJ-42847922 20 mg | 0 | 71 |
| Total, all-cause mortality | Zolpidem | 0 | 73 |
| Total, other adverse events | Placebo | 22 | 75 |
| Total, other adverse events | JNJ-42847922 5 mg | 16 | 72 |
| Total, other adverse events | JNJ-42847922 10 mg | 10 | 73 |
| Total, other adverse events | JNJ-42847922 20 mg | 13 | 71 |
| Total, other adverse events | Zolpidem | 21 | 73 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40802194 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Choice Reaction Time | Secondary outcome | ConductCognition |
| Delayed Recall Module | Secondary outcome | ConductCognition |
| Simple Reaction Time | Secondary outcome | ConductCognition |
| Spatial Working Memory | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03375203
GET https://conductscience.org/api/trials/v1/NCT03375203/registered?page=2