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

Insomnia Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841709
• Other study ID #: AC-078A202
• Status: Completed
• Phase: Phase 2
• Start date: November 28, 2016
• Est. completion date: June 29, 2017

Study information

• Verified date: April 2020
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 29, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• ACT-541468
Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
• Placebo
Capsules for oral administration matching the ACT-541468 capsules

Locations

Country	Name	City	State
Germany	Investigator Site	Berlin
Germany	Investigator Site	Berlin
Germany	Investigator Site	Hamburg
Germany	Investigator Site	Hannover
Germany	Investigator Site	Schwerin
United States	Investigator Site	Brandon	Florida
United States	Investigator Site	Chicago	Illinois
United States	Investigator Site	Cincinnati	Ohio
United States	Investigator Site	Las Vegas	Nevada
United States	Investigator Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline to Day 1 and Day 2 of each treatment period