Phase 3 double blind study of ACT-541468

JRCT ID: jRCT2031200452

Registered date:31/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Insomnia disorder
• Date of first enrollment: 26/04/2021
• Target sample size: 456
• Study type: Interventional
• Intervention(s): Adiministration of ACT-541468 25 mg, 50 mg or placebo once daily at bedtime for 4 weeks in subjects with insomnia.

Outcome(s)

• Primary Outcome: Subjective total sleep time, Subjective latency to sleep onset

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kawashima Takayuki
• Secondary Sponsor: Mochida Pharmaceutical Co.,Ltd.