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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Insomnia Disorder

Treatments: Drug: Placebo 2; Drug: ACT-541468 10 mg; Drug: ACT-541468 25 mg; Drug: Placebo 1; Drug: ACT-541468 5 mg; Drug: Zolpidem

Study type: Interventional

Funder types: Industry

Identifiers

NCT02839200

AC-078A201

Details and patient eligibility

About

This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.

Full description

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

Enrollment: 360 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 6 patient groups, including a placebo group

ACT-541468 5 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo 1

Drug: ACT-541468 5 mg

ACT-541468 10 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo 1

Drug: ACT-541468 10 mg

ACT-541468 25 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo 1

Drug: ACT-541468 25 mg

ACT-541468 50 mg

Experimental group

Description:

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

Treatment:

Drug: ACT-541468 25 mg

Zolpidem

Active Comparator group

Description:

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

Treatment:

Drug: Placebo 2

Drug: Zolpidem

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo 1