search
Back to results

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

Primary Purpose

Insomnia Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACT-541468 5 mg
ACT-541468 10 mg
ACT-541468 25 mg
Zolpidem
Placebo 1
Placebo 2
Sponsored by
Idorsia Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Disorder focused on measuring Insomnia, Polysomnography

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

ACT-541468 5 mg

ACT-541468 10 mg

ACT-541468 25 mg

ACT-541468 50 mg

Zolpidem

Placebo

Arm Description

Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks

Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks

Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks

Each subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks

Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks

Each subject receives two placebo capsules, once daily in the evening for 4 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
July 18, 2016
Last Updated
April 1, 2020
Sponsor
Idorsia Pharmaceuticals Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02839200
Brief Title
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
April 12, 2017 (Actual)
Study Completion Date
June 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder
Keywords
Insomnia, Polysomnography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT-541468 5 mg
Arm Type
Experimental
Arm Description
Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
Arm Title
ACT-541468 10 mg
Arm Type
Experimental
Arm Description
Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
Arm Title
ACT-541468 25 mg
Arm Type
Experimental
Arm Description
Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
Arm Title
ACT-541468 50 mg
Arm Type
Experimental
Arm Description
Each subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
Arm Title
Zolpidem
Arm Type
Active Comparator
Arm Description
Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each subject receives two placebo capsules, once daily in the evening for 4 weeks
Intervention Type
Drug
Intervention Name(s)
ACT-541468 5 mg
Intervention Description
Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Intervention Type
Drug
Intervention Name(s)
ACT-541468 10 mg
Intervention Description
Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Intervention Type
Drug
Intervention Name(s)
ACT-541468 25 mg
Intervention Description
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Intervention Type
Drug
Intervention Name(s)
Zolpidem
Intervention Description
Over-encapsulated zolpidem tablet at a strength of 10 mg
Intervention Type
Drug
Intervention Name(s)
Placebo 1
Intervention Description
Placebo capsules matching ACT-541468 capsules
Intervention Type
Drug
Intervention Name(s)
Placebo 2
Intervention Description
Placebo capsules matching over-encapsulated zolpidem
Primary Outcome Measure Information:
Title
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2
Description
WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)
Time Frame
Baseline and Days 1&2
Secondary Outcome Measure Information:
Title
Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2
Description
LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG
Time Frame
Baseline and Days 1&2
Title
Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4
Description
sLSO is the self-reported time to fall asleep, as reported in the sleep diary
Time Frame
Baseline and Week 4
Title
Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4
Description
sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.
Time Frame
Baseline and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Idorsia Pharmaceuticals Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Investigator Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Investigator Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Investigator Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Investigator Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Investigator Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Investigator Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Investigator Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Investigator Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Investigator Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Investigator Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Investigator Site
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Investigator Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Investigator Site
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Investigator Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Investigator Site
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
Investigator Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigator Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Investigator Site
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Facility Name
Investigator Site
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Investigator Site
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Investigator Site
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Investigator Site
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
Facility Name
Investigator Site
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Investigator Site
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Investigator Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Investigator Site
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Investigator Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Investigator Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Investigator Site
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Investigator Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigator Site
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Facility Name
Investigator Site
City
Zaragoza
ZIP/Postal Code
50015
Country
Spain
Facility Name
Investigator Site
City
Göteborg
ZIP/Postal Code
413 90
Country
Sweden
Facility Name
Investigator Site
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
31953863
Citation
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. Erratum In: Ann Neurol. 2020 Sep;88(3):647-651.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs