Insomnia DisorderPhase 2NCT02839200

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

A Phase 2 study testing ACT-541468 5 mg, ACT-541468 10 mg and ACT-541468 25 mg in people with Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 35 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Insomnia Disorder
What is being tested?: ACT-541468 5 mg, ACT-541468 10 mg and ACT-541468 25 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: 35 sitesin 6 countries
Study dates: 4 Oct 2016to 20 Jun 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Principal inclusion Criteria:

Signed informed consent prior to any study-mandated procedure.
Male or female aged 18-64 years (inclusive).
Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT.
Body mass index (BMI): 18.5 ≤ BMI (kg/m2) < 32.0.
Insomnia disorder according to DSM-5 criteria.
Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
Insomnia Severity Index score ≥ 15.

Principal exclusion Criteria:

Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
Caffeine consumption ≥ 600 mg per day.
Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel > or= 3 time zones during study.
Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
AST and/or ALT > 2 × ULN and/or direct bilirubin > 1.5 × ULN (except known history of Gilbert's syndrome).
Severe renal impairment (known or defined as estimated creatinine clearance < 30 mL/min).
History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

Trial locations and contacts

35 sites in 6 countries.

Country

City, postcode or hospital

35 sites in 6 countries

United States15 sites

Investigator Site
Atlanta, Georgia, 30342
Investigator Site
Brandon, Florida, 33511
Investigator Site
Chicago, Illinois, 60634
Investigator Site
Cincinnati, Ohio, 45255
Investigator Site
Clearwater, Florida, 33765
Investigator Site
Coral Gables, Florida, 33134
Investigator Site
DeLand, Florida, 32720
Investigator Site
Hollywood, Florida, 33024
Investigator Site
Indianapolis, Indiana, 46250
Investigator Site
Las Vegas, Nevada, 89104
Investigator Site
Miami, Florida, 33143
Investigator Site
New York, New York, 10019
Investigator Site
Novi, Michigan, 48377
Investigator Site
Santa Monica, California, 90404
Investigator Site
Upland, California, 91786

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Germany9 sites

Investigator Site
Berlin, 10115
Investigator Site
Berlin, 10117
Investigator Site
Berlin, 12203
Investigator Site
Dresden, 01069
Investigator Site
Hamburg, 20251
Investigator Site
Hamburg, 20253
Investigator Site
Hanover, 30159
Investigator Site
Schwerin, 19053
Investigator Site
Schwerin, 19055

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Spain4 sites

Investigator Site
Barcelona, 08017
Investigator Site
Barcelona, 08035
Investigator Site
Madrid, 28036
Investigator Site
Zaragoza, 50015

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Hungary3 sites

Investigator Site
Budapest, 1134
Investigator Site
Szeged, 6725
Investigator Site
Törökbálint, 2045

Other trials in Hungary

Israel2 sites

Investigator Site
Beersheba, 84101
Investigator Site
Haifa, 31096

Other trials in Israel

Sweden2 sites

Investigator Site
Gothenburg, 413 90
Investigator Site
Örebro, 701 85

Other trials in Sweden

About this study

Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Active-reference, Parallel-group, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.

Read the detailed description

This study consists of the following phases: screening phase; double-blind treatment phase; safety follow-up phase. Safety is monitored throughout the study.

Conditions: Insomnia Disorder
Being tested: ACT-541468 5 mg, ACT-541468 10 mg, ACT-541468 25 mg, Zolpidem, Placebo 1
Keywords: Insomnia, Polysomnography
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACT-541468 5 mgDrug
Capsule for oral administration containing ACT-541468 at a strength of 5 mg
ACT-541468 10 mgDrug
Capsule for oral administration containing ACT-541468 at a strength of 10 mg
ACT-541468 25 mgDrug
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
ZolpidemDrug
Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 1Drug
Placebo capsules matching ACT-541468 capsules
Placebo 2Drug
Placebo capsules matching over-encapsulated zolpidem

Study groups in NCT02839200
Study group	Role	What they receive
ACT-541468 5 mg	Experimental	Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks Receives: Drug: ACT-541468 5 mg; Drug: Placebo 1
ACT-541468 10 mg	Experimental	Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks Receives: Drug: ACT-541468 10 mg; Drug: Placebo 1
ACT-541468 25 mg	Experimental	Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks Receives: Drug: ACT-541468 25 mg; Drug: Placebo 1
ACT-541468 50 mg	Experimental	Each subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks Receives: Drug: ACT-541468 25 mg
Zolpidem	Active comparator	Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks Receives: Drug: Zolpidem; Drug: Placebo 2
Placebo	Placebo comparator	Each subject receives two placebo capsules, once daily in the evening for 4 weeks Receives: Drug: Placebo 1

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2
WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)
Measured: Baseline and Days 1&2

Secondary outcomes (3)

Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2
LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG
Measured: Baseline and Days 1&2
Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4
sLSO is the self-reported time to fall asleep, as reported in the sleep diary
Measured: Baseline and Week 4
Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4
sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.
Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 201620 Jun 2017

First posted20 Jul 2016 (estimated)
Study start4 Oct 2016
Primary completion12 Apr 2017
Study completion20 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Insomnia DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02839200
Sponsor's protocol ID: AC-078A201
Status last verified: Apr 2020
First submitted: 18 Jul 2016
Last updated: 13 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Dutta S, Singhal S, Shah R, Charan J, Dhingra S, Haque M. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1237-1251. doi: 10.1080/14740338.2023.2243217. Epub 2023 Aug 7.
PubMed 37526060
Di Marco T, Scammell TE, Meinel M, Seboek Kinter D, Datta AN, Zammit G, Dauvilliers Y. Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem. CNS Drugs. 2023 Jul;37(7):639-653. doi: 10.1007/s40263-023-01020-9. Epub 2023 Jul 21.
PubMed 37477771
Dauvilliers Y, Zammit G, Fietze I, Mayleben D, Seboek Kinter D, Pain S, Hedner J. Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder. Ann Neurol. 2020 Mar;87(3):347-356. doi: 10.1002/ana.25680. Epub 2020 Feb 5.
PubMed 31953863

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Active-reference, Parallel-group, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
ClinicalTrials.gov ID: NCT02839200
Acronym / sponsor ID: AC-078A201
Conditions: Insomnia Disorder
Keywords: Insomnia, Polysomnography
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
Study start: 4 Oct 2016 (actual)
Primary completion: 12 Apr 2017 (actual)
Study completion: 20 Jun 2017 (actual)
First posted: 20 Jul 2016 (estimated)
Results: Posted 2 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.

Detailed description

This study consists of the following phases: screening phase; double-blind treatment phase; safety follow-up phase. Safety is monitored throughout the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
ACT-541468 5 mg	Experimental	Drug: ACT-541468 5 mg, Drug: Placebo 1Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg	Experimental	Drug: ACT-541468 10 mg, Drug: Placebo 1Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 25 mg	Experimental	Drug: ACT-541468 25 mg, Drug: Placebo 1Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 50 mg	Experimental	Drug: ACT-541468 25 mgEach subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
Zolpidem	Active comparator	Drug: Zolpidem, Drug: Placebo 2Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Placebo	Placebo comparator	Drug: Placebo 1Each subject receives two placebo capsules, once daily in the evening for 4 weeks

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACT-541468 5 mgCapsule for oral administration containing ACT-541468 at a strength of 5 mg	Drug	ACT-541468 5 mg
ACT-541468 10 mgCapsule for oral administration containing ACT-541468 at a strength of 10 mg	Drug	ACT-541468 10 mg
ACT-541468 25 mgCapsule for oral administration containing ACT-541468 at a strength of 25 mg	Drug	ACT-541468 25 mg, ACT-541468 50 mg
ZolpidemOver-encapsulated zolpidem tablet at a strength of 10 mg	Drug	Zolpidem
Placebo 1Placebo capsules matching ACT-541468 capsules	Drug	ACT-541468 10 mg, ACT-541468 25 mg, ACT-541468 5 mg, Placebo
Placebo 2Placebo capsules matching over-encapsulated zolpidem	Drug	Zolpidem

Primary outcome

Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2
Time frame: 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)

3 secondary outcomes

Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2
Time frame: Baseline and Days 1&2
Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4
Time frame: Baseline and Week 4
Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4
Time frame: Baseline and Week 4

Results and safety

Results posted to the registry on 2 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACT-541468 5 mg	60	56
ACT-541468 10 mg	59	58
ACT-541468 25 mg	60	59
ACT-541468 50 mg	61	61
Zolpidem	60	58
Placebo	60	59

Primary outcome: Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2

Time frame: Baseline and Days 1&2. Least squares mean (Standard Error). Unit: minutes

Measure	ACT-541468 5 mg n = 60	ACT-541468 10 mg n = 58	ACT-541468 25 mg n = 60	ACT-541468 50 mg n = 61	Zolpidem n = 60	Placebo n = 60
Value	-28.4 (4.24)	-32.3 (4.32)	-37.7 (4.25)	-47.1 (4.21)	-29.9 (4.30)	-21.4 (4.24)

ACT-541468 5 mg vs ACT-541468 10 mg vs ACT-541468 25 mg vs ACT-541468 50 mg vs Placebo: p <0.001, Multiple Comparison Procedure-Model
ACT-541468 5 mg vs Placebo: LS mean difference: -7 (95% CI -18.7 to 4.7), p = 0.241, ANCOVA
ACT-541468 10 mg vs Placebo: LS Mean difference: -10.8 (95% CI -22.6 to 1), p = 0.072, ANCOVA

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACT-541468 5 mg	0 of 60 (0%)	21 of 60 (35%)	0 of 60
ACT-541468 10 mg	2 of 58 (3.4%)	22 of 58 (37.9%)	0 of 58
ACT-541468 25 mg	0 of 60 (0%)	23 of 60 (38.3%)	0 of 60
ACT-541468 50 mg	1 of 61 (1.6%)	21 of 61 (34.4%)	0 of 61
Zolpidem	0 of 60 (0%)	24 of 60 (40%)	0 of 60
Placebo	0 of 60 (0%)	18 of 60 (30%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37526060Dutta S, Singhal S, Shah R, Charan J, Dhingra S, Haque M. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1237-1251. doi: 10.1080/14740338.2023.2243217. Epub 2023 Aug 7.
Derived from this study: PubMed 37477771Di Marco T, Scammell TE, Meinel M, Seboek Kinter D, Datta AN, Zammit G, Dauvilliers Y. Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem. CNS Drugs. 2023 Jul;37(7):639-653. doi: 10.1007/s40263-023-01020-9. Epub 2023 Jul 21.
Derived from this study: PubMed 31953863Dauvilliers Y, Zammit G, Fietze I, Mayleben D, Seboek Kinter D, Pain S, Hedner J. Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder. Ann Neurol. 2020 Mar;87(3):347-356. doi: 10.1002/ana.25680. Epub 2020 Feb 5.

Related trials for Insomnia Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Idorsia Pharmaceuticals Ltd.

35 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACT-541468 5 mg, ACT-541468 10 mg and ACT-541468 25 mg in people with Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 35 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Germany, Spain, Hungary, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 (time frame: Baseline and Days 1&2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02839200, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.