A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients With Insomnia Disorder.

  • End date
    Jan 24, 2024
  • participants needed
  • sponsor
    Taisho Pharmaceutical Co., Ltd.
Updated on 24 October 2022


This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.

Condition Patients With Insomnia
Treatment TS-142 5 mg, TS-142 10 mg, Placebo to TS-142
Clinical Study IdentifierNCT05453136
SponsorTaisho Pharmaceutical Co., Ltd.
Last Modified on24 October 2022


Yes No Not Sure

Inclusion Criteria

Japanese male and female who are aged 18 years or older at the time of informed consent
Patients falling under the category of insomnia disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
Other protocol defined inclusion criteria could apply

Exclusion Criteria

Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
Patients with psychiatric disorders such as depression, schizophrenia, and anxiety
Patients with difficulty sleeping due to medical problems such as pain, pruritus, hot flush, nocturia (> 3 times per night), heart disease, bronchial asthma, reflux esophagitis, endocrine disease, and periodic limb movement disorder
Other protocol defined exclusion criteria could apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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