RecruitingNot Applicable

Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

United States, Canada, France785 participantsStarted 2024-11-21

Plain-language 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.

Who can participate

Age range15 Years – 50 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. Diagnosis of insomnia disorder prior to pregnancy.
✕. Pregnancy has ended.
✕. Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.

What they're measuring

Major congenital malformations classified according to MACDP

Timeframe: Start of pregnancy up to 1 year of infant age

Trial details

NCT IDNCT06498128

SponsorIdorsia Pharmaceuticals Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2033-03

Contact for this trial

Clinical Trial Information USA

+1 856 661 37 21 idorsiaclinicaltrials@idorsia.com

View on ClinicalTrials.gov More Insomnia trials