Trial · NCT03545191
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
NCT03545191, Phase 3, Completed, Idorsia Pharmaceuticals Ltd.; results first posted 2022-03-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder. Trials, record NCT03545191. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03545191
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
- NCT number
- NCT03545191
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 930 participants, actual
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Conditions
- Insomnia Disorder
- Interventions
- Daridorexant 25 mg, Daridorexant 50 mg, Placebo
- First posted
- 2018-06-04
- Last updated
- 2022-03-25
- Results first posted
- 2022-03-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) | From baseline to Month 1 (i.e. for up to 1 month) | "Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography. |
| Primary | Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) | From baseline to Month 3 (i.e. for up to 3 months) | "Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography. |
| Primary | Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) | From baseline to Month 1 (i.e. for up to 1 month) | "Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography. |
| Primary | Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS) | From baseline to Month 3 (i.e. for up to 3 months) | "Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography. |
| Secondary | Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST) | From baseline to Month 1 (i.e. for up to 1 month) | "Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time. |
| Secondary | Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST) | From baseline to Month 3 (i.e. for up to 3 months) | "Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time. |
| Secondary | Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score | From baseline to Month 1 (i.e. for up to 1 month) | The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
| Secondary | Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score | From baseline to Month 3 (i.e. for up to 3 months) | The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) | From baseline to Month 1 (i.e. for up to 1 month) | minutes | LEAST_SQUARES_MEAN | |
| PRIMARY | Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) | From baseline to Month 3 (i.e. for up to 3 months) | minutes | LEAST_SQUARES_MEAN | |
| PRIMARY | Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) | From baseline to Month 1 (i.e. for up to 1 month) | minutes | LEAST_SQUARES_MEAN | |
| PRIMARY | Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS) | From baseline to Month 3 (i.e. for up to 3 months) | minutes | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST) | From baseline to Month 1 (i.e. for up to 1 month) | minutes | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST) | From baseline to Month 3 (i.e. for up to 3 months) | minutes | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score | From baseline to Month 1 (i.e. for up to 1 month) | Scores on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score | From baseline to Month 3 (i.e. for up to 3 months) | Scores on a scale | LEAST_SQUARES_MEAN | |
| POST_HOC | Change From Baseline to Month 1 in Log-transformed LPS (LSGM Ratio to Baseline) | From baseline to Month 1 (i.e. for up to 1 month) | minutes | GEOMETRIC_LEAST_SQUARES_MEAN | |
| POST_HOC | Change From Baseline to Month 3 in Log-transformed LPS (LSGM Ratio to Baseline) | From baseline to Month 3 (i.e. for up to 3 month) | minutes | GEOMETRIC_LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) | Daridorexant 25 mg | -18.40 | 95% Confidence Interval -22.126 to -14.674 | minutes | |
| Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) | Daridorexant 50 mg | -28.98 | 95% Confidence Interval -32.668 to -25.299 | minutes | |
| Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) | Placebo | -6.20 | 95% Confidence Interval -9.928 to -2.475 | minutes | |
| Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) | Daridorexant 25 mg | -22.97 | 95% Confidence Interval -26.955 to -18.988 | minutes | |
| Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) | Daridorexant 50 mg | -29.41 | 95% Confidence Interval -33.399 to -25.427 | minutes | |
| Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) | Placebo | -11.11 | 95% Confidence Interval -15.131 to -7.088 | minutes | |
| Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) | Daridorexant 25 mg | -28.17 | 95% Confidence Interval -31.509 to -24.827 | minutes | |
| Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) | Daridorexant 50 mg | -31.20 | 95% Confidence Interval -34.506 to -27.896 | minutes | |
| Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) | Placebo | -19.85 | 95% Confidence Interval -23.177 to -16.515 | minutes | |
| Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS) | Daridorexant 25 mg | -30.73 | 95% Confidence Interval -34.037 to -27.417 | minutes |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daridorexant 25 mg | 310 | |
| Overall Study | STARTED | Daridorexant 50 mg | 310 | |
| Overall Study | STARTED | Placebo | 310 | |
| Overall Study | COMPLETED | Daridorexant 25 mg | 288 | |
| Overall Study | COMPLETED | Daridorexant 50 mg | 285 | |
| Overall Study | COMPLETED | Placebo | 280 | |
| Overall Study | NOT COMPLETED | Daridorexant 25 mg | 22 | |
| Overall Study | NOT COMPLETED | Daridorexant 50 mg | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 30 |
Source ClinicalTrials.gov
Adverse events42
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 | Headache | Nervous system disorders | Daridorexant 25 mg | 17 | 310 | 24 |
| other | Headache | Nervous system disorders | Daridorexant 50 mg | 20 | 308 | 27 |
| other | Headache | Nervous system disorders | Placebo | 12 | 309 | 18 |
| other | Nasopharyngitis | Infections and infestations | Daridorexant 25 mg | 28 | 310 | 28 |
| other | Nasopharyngitis | Infections and infestations | Daridorexant 50 mg | 24 | 308 | 26 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 24 | 309 | 29 |
| serious | Post procedural haemorrhage | Injury, poisoning and procedural complications | Daridorexant 25 mg | 0 | 310 | 0 |
| serious | Post procedural haemorrhage | Injury, poisoning and procedural complications | Daridorexant 50 mg | 1 | 308 | 1 |
| serious | Post procedural haemorrhage | Injury, poisoning and procedural complications | Placebo | 0 | 309 | 0 |
| serious | Ankle fracture | Injury, poisoning and procedural complications | Daridorexant 25 mg | 0 | 310 | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daridorexant 25 mg | 1 | 310 |
| Total, all-cause mortality | Daridorexant 50 mg | 0 | 308 |
| Total, all-cause mortality | Placebo | 0 | 309 |
| Total, other adverse events | Daridorexant 25 mg | 44 | 310 |
| Total, other adverse events | Daridorexant 50 mg | 41 | 308 |
| Total, other adverse events | Placebo | 35 | 309 |
| Total, serious adverse events | Daridorexant 25 mg | 2 | 310 |
| Total, serious adverse events | Daridorexant 50 mg | 3 | 308 |
| Total, serious adverse events | Placebo | 7 | 309 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
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.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT03545191
GET https://conductscience.org/api/trials/v1/NCT03545191/results?page=2