A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
← catalyst calendarSponsored by Eisai Inc. (industry) · 4523.T — their whole pipeline →.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
861estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-01-03 | actual | When the study began enrolling |
| Primary completion | 2025-12-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-30 | estimated | The whole study's end, after follow-up |
| First posted | 2024-12-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-06-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Sleep Initiation and Maintenance Disorders
- Pregnancy
Intervention
- Other: No Intervention
Primary outcomes
what the primary-completion date above is the date OFPercentage of Live Births Reported With MCM in Women of Cohort A Subset and Cohort C
measured At estimated date of delivery (EDD)/pregnancy outcome (up to 1 year 10 months)
Percentage of Live Births Reported With MCM in Women of Cohort A and Cohort B Subsets
measured At EDD/pregnancy outcome (up to 1 year 10 months)
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