JPRN-jRCT2031200452CompletedPhase 3
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.
Kawashima Takayuki0 sites490 target enrollmentStarted: March 31, 2021Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 490
Study Overview
Brief Summary
The results of this study showed that ACT-541468 is a useful therapeutic drug in the treatment of insomnia disorders, because it improved difficulty falling sleep and prolonged sleep duration in patients with insomnia disorders, without carryover effects, and it was confirmed to have good safety and tolerability.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
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
- •(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.
Investigators
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