Status:
RECRUITING
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Insomnia
Eligibility:
FEMALE
15-50 years
Brief Summary
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Eligibility Criteria
Inclusion
- A) Eligibility criteria for prospective pregnancies:
- Diagnosis of insomnia disorder prior to pregnancy.
- Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.
- One of the following:
- Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.
- Exposure to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
- No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.
Exclusion
- Exposure to any orexin receptor antagonist other than QUVIVIQ - including BELSOMRA® (suvorexant), DAYVIGO® (lemborexant), any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during the current pregnancy or within 5 half-lives of the respective medication prior to conception.
- B) Eligibility criteria for retrospective pregnancies:
- Inclusion criteria:
- Diagnosis of insomnia disorder prior to pregnancy.
- Pregnancy has ended.
- Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
- Exclusion criteria:
- Exposure to any orexin receptor antagonist other than QUVIVIQ - including suvorexant, lemborexant, any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during pregnancy or within 5 half-lives of the respective medication prior to conception.
Key Trial Info
Start Date :
November 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2033
Estimated Enrollment :
785 Patients enrolled
Trial Details
Trial ID
NCT06498128
Start Date
November 21 2024
End Date
March 1 2033
Last Update
December 2 2025
Active Locations (7)
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1
IQVIA US Office
Durham, North Carolina, United States, 27703
2
Jodha Tishon
Toronto, Ontario, Canada
3
Hôpital Gui de Chauliac
Montpellier, France
4
Charité - Universitätsmedizin Berlin
Berlin, Germany