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

Insomnia Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839200
• Other study ID #: AC-078A201
• Status: Completed
• Phase: Phase 2
• Start date: October 4, 2016
• Est. completion date: June 20, 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 WASO from baseline to Days 1 and 2, assessed by PSG.

Description:

This study consists of the following phases: screening phase; double-blind treatment phase; safety follow-up phase. Safety is monitored throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 20, 2017
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• ACT-541468 5 mg
Capsule for oral administration containing ACT-541468 at a strength of 5 mg
• ACT-541468 10 mg
Capsule for oral administration containing ACT-541468 at a strength of 10 mg
• ACT-541468 25 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
• Zolpidem
Over-encapsulated zolpidem tablet at a strength of 10 mg
• Placebo 1
Placebo capsules matching ACT-541468 capsules
• Placebo 2
Placebo capsules matching over-encapsulated zolpidem

Locations

Country	Name	City	State
Germany	Investigator Site	Berlin
Germany	Investigator Site	Berlin
Germany	Investigator Site	Berlin
Germany	Investigator Site	Dresden
Germany	Investigator Site	Hamburg
Germany	Investigator Site	Hamburg
Germany	Investigator Site	Hannover
Germany	Investigator Site	Schwerin
Germany	Investigator Site	Schwerin
Hungary	Investigator Site	Budapest
Hungary	Investigator Site	Szeged
Hungary	Investigator Site	Törökbálint
Israel	Investigator Site	Beer Sheva
Israel	Investigator Site	Haifa
Spain	Investigator Site	Barcelona
Spain	Investigator Site	Barcelona
Spain	Investigator Site	Madrid
Spain	Investigator Site	Zaragoza
Sweden	Investigator Site	Göteborg
Sweden	Investigator Site	Örebro
United States	Investigator Site	Atlanta	Georgia
United States	Investigator Site	Brandon	Florida
United States	Investigator Site	Chicago	Illinois
United States	Investigator Site	Cincinnati	Ohio
United States	Investigator Site	Clearwater	Florida
United States	Investigator Site	Coral Gables	Florida
United States	Investigator Site	DeLand	Florida
United States	Investigator Site	Hollywood	Florida
United States	Investigator Site	Indianapolis	Indiana
United States	Investigator Site	Las Vegas	Nevada
United States	Investigator Site	Miami	Florida
United States	Investigator Site	New York	New York
United States	Investigator Site	Novi	Michigan
United States	Investigator Site	Santa Monica	California
United States	Investigator Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Israel,  Spain,  Sweden, 

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 and Days 1&2
Secondary	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	Baseline and Days 1&2
Secondary	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	Baseline and Week 4
Secondary	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.	Baseline and Week 4