Efficacy validation through a clinical trial of an app for treating insomnia
First written in FY2022-Q2. 3 of 4 entries say "Restated". Latest entry: FY2023.
No other company in this theme has enough history to compare yet.
- FY2023RestatedAnnual report
「The confirmatory trial achieved its primary endpoint, and in February 2023 the Company obtained marketing authorization for the medical device from the Ministry of Health, Labour and Welfare.」
The achievement of the primary endpoint in the confirmatory trial of the therapeutic application for insomnia disorder is reiterated. - FY2022RestatedAnnual report
「In the DTx Product Business, the Company achieved the primary endpoint in the confirmatory trial of the therapeutic application for insomnia disorder, equivalent to a Phase III clinical trial, the final stage of clinical development.」
The completion of the confirmatory trial and achievement of the primary endpoint are also reiterated in the annual report. - FY2022-Q3RestatedAnnual report
「During the cumulative third quarter, the Company completed the confirmatory trial of the therapeutic application for insomnia disorder and achieved the primary endpoint in the clinical trial.」
The completion of the confirmatory trial and achievement of the primary endpoint are reiterated. - FY2022-Q2AdvancedAnnual report
「During the cumulative second quarter, the Company completed the confirmatory trial of the therapeutic application for insomnia disorder (the “Application”) in November and achieved the primary endpoint in the clinical trial.」
The Company states that, following completion of the confirmatory trial, a statistically significant difference in improvement on the Athens Insomnia Scale was observed between the therapeutic application group and the sham group.