Phase 3 double blind study of ACT-541468

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase III Clinical Study to Investigate the Efficacy and Safety of ACT-541468 in Patients with Insomnia Disorder.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200452

Enrollment

456

Registered

2021-03-31

Start date

2021-04-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia disorder

Interventions

Adiministration of ACT-541468 25 mg, 50 mg or placebo once daily at bedtime for 4 weeks in subjects with insomnia.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients who consent to participate in the clinical study by signing a document prior to the commencement of the clinical trial procedure (if the subject is under 20 years old, subjects written consent from the legally acceptable representative musct be obtained in addition to the subject). (2)Men and women aged 18 years or older (at the time of informed consent) (3)Subjects diagnosed with insomnia disorder according to DSM-5 criteria.

Exclusion criteria

Exclusion criteria: (1)BMI >= 30.0 kg/m^2. (2)Subjects with a history or complication of sleep-related breathing disorders such as chronic obstructive pulmonary disease. (3)Subjects with a history or complication of sleep apnea syndrome. (4)Subjects with cognitive behavioral therapy (CBT) as treatment for insomnia disorder 4 weeks prior to Visit 1 or subjjects scheduled to undergo CBT during the study period. (5)Subjects with periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movemen (REM) sleep behavior disorder, or narcolepsy. (6)Self-reported usual daytime napping >= 1 hour per day, and >= 3 days per week. (7)Subjects with acute or unstable or psychiatric disorders (e.g. anxiety disorder, major depression, bipolar disorder, schizophrenia, obssive compulsive disorder) requiring treatment or subjects diagnosed as having a psychiatric disorder according to Mini International Neuropsychiatric Interview (M.I.N.I.). (8)Subjects aged 50 years or older, with a Mini Mental State Examination (MMSE-J) score of less than 25.

Design outcomes

Primary

Measure	Time frame
Subjective total sleep time, Subjective latency to sleep onset	—

Contacts

Public ContactTakayuki Kawashima

Idorsia Pharmaceuticals Japan Ltd.

chiken.info-jp@idorsia.com+81-3-5962-5600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026