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

April 1, 2020 updated by: Idorsia Pharmaceuticals Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Investigator Site
      • Berlin, Germany, 10117
        • Investigator Site
      • Berlin, Germany, 12203
        • Investigator Site
      • Dresden, Germany, 01069
        • Investigator Site
      • Hamburg, Germany, 20253
        • Investigator Site
      • Hamburg, Germany, 20251
        • Investigator Site
      • Hannover, Germany, 30159
        • Investigator Site
      • Schwerin, Germany, 19053
        • Investigator Site
      • Schwerin, Germany, 19055
        • Investigator Site
  • Hungary
      • Budapest, Hungary, 1134
        • Investigator Site
      • Szeged, Hungary, 6725
        • Investigator Site
      • Törökbálint, Hungary, 2045
        • Investigator Site
  • Israel
      • Beer Sheva, Israel, 84101
        • Investigator Site
      • Haifa, Israel, 31096
        • Investigator Site
  • Spain
      • Barcelona, Spain, 08035
        • Investigator Site
      • Barcelona, Spain, 08017
        • Investigator Site
      • Madrid, Spain, 28036
        • Investigator Site
      • Zaragoza, Spain, 50015
        • Investigator Site
  • Sweden
      • Göteborg, Sweden, 413 90
        • Investigator Site
      • Örebro, Sweden, 701 85
        • Investigator Site
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Investigator Site
      • Upland, California, United States, 91786
        • Investigator Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Investigator Site
      • Clearwater, Florida, United States, 33765
        • Investigator Site
      • Coral Gables, Florida, United States, 33134
        • Investigator Site
      • DeLand, Florida, United States, 32720
        • Investigator Site
      • Hollywood, Florida, United States, 33024
        • Investigator Site
      • Miami, Florida, United States, 33143
        • Investigator Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Investigator Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Investigator Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Investigator Site
    • Michigan
      • Novi, Michigan, United States, 48377
        • Investigator Site
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Investigator Site
    • New York
      • New York, New York, United States, 10019
        • Investigator Site
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT-541468 5 mg
Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
Drug: ACT-541468 5 mg
Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules
Experimental: ACT-541468 10 mg
Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules
Drug: ACT-541468 10 mg
Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Experimental: ACT-541468 25 mg
Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules
Drug: ACT-541468 25 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Experimental: ACT-541468 50 mg
Each subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
Drug: ACT-541468 25 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Active Comparator: Zolpidem
Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Drug: Zolpidem
Over-encapsulated zolpidem tablet at a strength of 10 mg
Drug: Placebo 2
Placebo capsules matching over-encapsulated zolpidem
Placebo Comparator: Placebo
Each subject receives two placebo capsules, once daily in the evening for 4 weeks
Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline and Days 1&2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2
Time Frame: Baseline and Days 1&2
LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG
Baseline and Days 1&2
Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4
Time Frame: Baseline and Week 4
sLSO is the self-reported time to fall asleep, as reported in the sleep diary
Baseline and Week 4
Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4
Time Frame: Baseline and Week 4
sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Idorsia Pharmaceuticals Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-078A201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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