Trial · NCT02839200

Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

NCT02839200, Phase 2, Completed, Idorsia Pharmaceuticals Ltd.; results first posted 2020-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder. Trials, record NCT02839200. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02839200

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
NCT number: NCT02839200
Status: Completed
Phases: Phase 2
Enrollment: 360 participants, actual
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Conditions: Insomnia Disorder
Interventions: ACT-541468 5 mg, ACT-541468 10 mg, ACT-541468 25 mg, Zolpidem, Placebo 1, Placebo 2
First posted: 2016-07-20
Last updated: 2020-04-13
Results first posted: 2020-04-02

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2	Baseline and Days 1&2	WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)
Secondary	Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2	Baseline and Days 1&2	LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG
Secondary	Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4	Baseline and Week 4	sLSO is the self-reported time to fall asleep, as reported in the sleep diary
Secondary	Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4	Baseline and Week 4	sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2	Baseline and Days 1&2	minutes	LEAST_SQUARES_MEAN
SECONDARY	Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2	Baseline and Days 1&2	Minutes	MEAN
SECONDARY	Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4	Baseline and Week 4	Minutes	MEAN
SECONDARY	Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4	Baseline and Week 4	Minutes	MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2	ACT-541468 5 mg	-28.4	Standard Error 4.24	minutes
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2	ACT-541468 10 mg	-32.3	Standard Error 4.32	minutes
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2	ACT-541468 25 mg	-37.7	Standard Error 4.25	minutes
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2	ACT-541468 50 mg	-47.1	Standard Error 4.21	minutes
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2	Zolpidem	-29.9	Standard Error 4.30	minutes
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2	Placebo	-21.4	Standard Error 4.24	minutes
Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2	ACT-541468 5 mg	-26.88	Standard Deviation 45.42	Minutes
Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2	ACT-541468 10 mg	-29.31	Standard Deviation 26.79	Minutes
Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2	ACT-541468 25 mg	-36.14	Standard Deviation 34.34	Minutes
Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2	ACT-541468 50 mg	-36.41	Standard Deviation 26.71	Minutes

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ACT-541468 5 mg	60
Overall Study	STARTED	ACT-541468 10 mg	59
Overall Study	STARTED	ACT-541468 25 mg	60
Overall Study	STARTED	ACT-541468 50 mg	61
Overall Study	STARTED	Zolpidem	60
Overall Study	STARTED	Placebo	60
Overall Study	COMPLETED	ACT-541468 5 mg	56
Overall Study	COMPLETED	ACT-541468 10 mg	58
Overall Study	COMPLETED	ACT-541468 25 mg	59
Overall Study	COMPLETED	ACT-541468 50 mg	61

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events684

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	Eosinophilia	Blood and lymphatic system disorders	ACT-541468 5 mg	0	60	0
other	Eosinophilia	Blood and lymphatic system disorders	ACT-541468 10 mg	1	58	1
other	Eosinophilia	Blood and lymphatic system disorders	ACT-541468 25 mg	0	60	0
other	Eosinophilia	Blood and lymphatic system disorders	ACT-541468 50 mg	0	61	0
other	Eosinophilia	Blood and lymphatic system disorders	Zolpidem	0	60	0
other	Eosinophilia	Blood and lymphatic system disorders	Placebo	0	60	0
other	Neutropenia	Blood and lymphatic system disorders	ACT-541468 5 mg	0	60	0
other	Neutropenia	Blood and lymphatic system disorders	ACT-541468 10 mg	1	58	1
other	Neutropenia	Blood and lymphatic system disorders	ACT-541468 25 mg	0	60	0
other	Neutropenia	Blood and lymphatic system disorders	ACT-541468 50 mg	0	61	0

1 to 10 of 684Source ClinicalTrials.gov

See all 684 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ACT-541468 5 mg	0	60
Total, all-cause mortality	ACT-541468 10 mg	0	58
Total, all-cause mortality	ACT-541468 25 mg	0	60
Total, all-cause mortality	ACT-541468 50 mg	0	61
Total, all-cause mortality	Zolpidem	0	60
Total, all-cause mortality	Placebo	0	60
Total, other adverse events	ACT-541468 5 mg	21	60
Total, other adverse events	ACT-541468 10 mg	22	58
Total, other adverse events	ACT-541468 25 mg	23	60
Total, other adverse events	ACT-541468 50 mg	21	61

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31953863	DERIVED	PubMed
37477771	DERIVED	PubMed
37526060	DERIVED	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.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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