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

Primary Purpose

Insomnia Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACT-541468
Placebo
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, elderly, Polysomnography

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure.
  • Male or female aged ≥ 65 years.
  • Body mass index (BMI): 18.5 ≤ BMI (kg/m2 ) < 32.0
  • Insomnia disorder according to DSM-5 criteria.
  • Self-reported history of insufficient sleep quantity.
  • Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
  • Insomnia Severity Index score ≥ 15.

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 ≥ 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 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Arm Description

Each subject participates in 5 treatment periods. On the evening of the first 2 days of each period they receive one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period is separated from the next one by a 5- to 12-day washout.

Each subject participates in 5 treatment periods. On the evening of the first 2 days of each period they receive one dose (D) of ACT-541468 or placebo orally in the following order: D2, P, D4, D3 and D1, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period is separated from the next one by a 5- to 12-day washout.

Each subject participates in 5 treatment periods. On the evening of the first 2 days of each period they receive one dose (D) of ACT-541468 or placebo orally in the following order: D3, D1, D2, P and D4, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period is separated from the next one by a 5- to 12-day washout.

Each subject participates in 5 treatment periods. On the evening of the first 2 days of each period they receive one dose (D) of ACT-541468 or placebo orally in the following order: P, D4, D1, D2, D3, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period is separated from the next one by a 5- to 12-day washout.

Each subject participates in 5 treatment periods. On the evening of the first 2 days of each period they receive one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period is separated from the next one by a 5- to 12-day washout.

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 Mean 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

Full Information

First Posted
July 20, 2016
Last Updated
April 22, 2020
Sponsor
Idorsia Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02841709
Brief Title
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Official Title
Multi-center, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 28, 2016 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
June 29, 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 wake after sleep onset (WASO) assessed by polysomnography (PSG) on the first 2 days of each treatment period.
Detailed Description
The study consists of 3 phases: a screening phase, a double-blind treatment phase consisting of 5 periods, and a 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, elderly, Polysomnography

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Each subject participates in 5 treatment periods. On the evening of the first 2 days of each period they receive one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period is separated from the next one by a 5- to 12-day washout.
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Each subject participates in 5 treatment periods. On the evening of the first 2 days of each period they receive one dose (D) of ACT-541468 or placebo orally in the following order: D2, P, D4, D3 and D1, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period is separated from the next one by a 5- to 12-day washout.
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Each subject participates in 5 treatment periods. On the evening of the first 2 days of each period they receive one dose (D) of ACT-541468 or placebo orally in the following order: D3, D1, D2, P and D4, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period is separated from the next one by a 5- to 12-day washout.
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
Each subject participates in 5 treatment periods. On the evening of the first 2 days of each period they receive one dose (D) of ACT-541468 or placebo orally in the following order: P, D4, D1, D2, D3, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period is separated from the next one by a 5- to 12-day washout.
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
Each subject participates in 5 treatment periods. On the evening of the first 2 days of each period they receive one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period is separated from the next one by a 5- to 12-day washout.
Intervention Type
Drug
Intervention Name(s)
ACT-541468
Intervention Description
Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules for oral administration matching the ACT-541468 capsules
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 to Day 1 and Day 2 of each treatment period
Secondary Outcome Measure Information:
Title
Change in Mean 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 to Day 1 and Day 2 of each treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to any study-mandated procedure. Male or female aged ≥ 65 years. Body mass index (BMI): 18.5 ≤ BMI (kg/m2 ) < 32.0 Insomnia disorder according to DSM-5 criteria. Self-reported history of insufficient sleep quantity. Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography. Insomnia Severity Index score ≥ 15. 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 ≥ 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 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
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Investigator Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
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
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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32341187
Citation
Zammit G, Dauvilliers Y, Pain S, Sebok Kinter D, Mansour Y, Kunz D. Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder. Neurology. 2020 May 26;94(21):e2222-e2232. doi: 10.1212/WNL.0000000000009475. Epub 2020 Apr 27.
Results Reference
derived

Learn more about this trial

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

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