The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
164
Daridorexant will be taken orally, once daily in the evening as indicated by investigator.
Placebo will be taken orally, once daily in the evening as indicated by investigator.
Inje University Busan Paik Hospital
Busan, South Korea
Pusan National University Yangsan Hospital
Busan, South Korea
Subjective total sleep time(sTST)
Change from baseline to week 4 in subjective total sleep time (sTST) measured by eDairy
Time frame: Week 4
Subjective latency to sleep onset (sLSO)
Change from baseline to week 4 in subjective latency to sleep onset (sLSO) measured by eDairy
Time frame: Week 4
Subjective wake after sleep onset (WASO)
Change from baseline to week 4 in subjective wake after sleep onset (WASO) measured by eDairy
Time frame: Week 4
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Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Catholic Kwandong University International St. Mary'S Hospital
Incheon, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
...and 7 more locations