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

NCT02841709 | Completed Phase 2 Results DMC

• 1 other identifier: AC-078A202
• Study Type: interventional
• Target: 58
• Locations: 2 countries
• Sites: 10

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.

Conditions

Insomnia Disorder

Keywords

insomnia; elderly; Polysomnography

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline to Day 1 and Day 2 of each treatment period

Secondary Outcomes (1)

• Change in Mean Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2

  Baseline to Day 1 and Day 2 of each treatment period

Study Arms (5)

Sequence 1

EXPERIMENTAL

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.

Drug: ACT-541468; Drug: Placebo

Sequence 2

EXPERIMENTAL

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.

Drug: ACT-541468; Drug: Placebo

Sequence 3

EXPERIMENTAL

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.

Drug: ACT-541468; Drug: Placebo

Sequence 4

EXPERIMENTAL

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.

Drug: ACT-541468; Drug: Placebo

Sequence 5

EXPERIMENTAL

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.

Drug: ACT-541468; Drug: Placebo

Interventions

ACT-541468 DRUG

Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5

Placebo DRUG

Capsules for oral administration matching the ACT-541468 capsules

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (10)

Investigator Site

Brandon, Florida, 33511, United States

Location

Investigator Site

Chicago, Illinois, 60634, United States

Location

Investigator Site

Las Vegas, Nevada, 89104, United States

Location

Investigator Site

New York, New York, 10019, United States

Location

Investigator Site

Cincinnati, Ohio, 45255, United States

Location

Investigator Site

Berlin, 10115, Germany

Location

Investigator Site

Berlin, 10117, Germany

Location

Investigator Site

Hamburg, 20253, Germany

Location

Investigator Site

Hanover, 30159, Germany

Location

Investigator Site

Schwerin, 19053, Germany

Location

Related Publications (1)

• 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.

  PMID: 32341187 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Clinical Trials Disclosure Desk
• Organization: Idorsia Pharmaceuticals Ltd

clinical-trials-disclosure@idorsia.com

+41 588 441977

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 22, 2016
• Study Start: November 28, 2016
• Primary Completion: May 31, 2017
• Study Completion: June 29, 2017
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); DE (5)