NCT02783729
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
See it on ClinicalTrials.gov ↗1,006 people
86.4%
13.6%
869 womenmiddle line = equal numbers137 men
- Phase
- PHASE3
- Paid for by
- Eisai Inc.
- Finished
- 2018-01-30
- Health conditions
- Insomnia
- Who could join
- Anyone
- Ages
- 55 Years – no maximum
- Average age
- mean 63.9 years
- Age 65+
- Not reported
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 72.3% · Black / African American 25.4% · Asian 1.4% · Other 0.7% · Native Hawaiian / Pacific Islander 0.2% · American Indian / Alaska Native 0%
Women left out
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“…y disease, acute and/or severe respiratory depression; gastrointestinal; severe hepatic impairment; renal including severe renal impairment; neurological including myasthenia gravis; psychiatric disease; or malignancy within the past 5 year…”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“Beck Depression Inventory - II (BDI-II) score \>19 at Screening”
- No cancer
Women with current or past cancer were turned away.
“…l impairment; neurological including myasthenia gravis; psychiatric disease; or malignancy within the past 5 years other than adequately treated basal cell carcinoma) or chronic pain that in the opinion of the investigator(s) could affect t…”
Study titles and rules are shown in their original English.