Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Recruiting now
Conditions studied: Insomnia
In brief
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Key facts
- Study ID
- NCT06498128
- Run by
- Idorsia Pharmaceuticals Ltd.
- People needed
- 785
- Starts
- 2024-11-21
- Expected to finish
- 2033-03-01
- Last updated by the study team
- 2025-12-02
Who can join
Age: 15 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- IQVIA US Office — Durham, North Carolina, United States (enrolling)
- Jodha Tishon — Toronto, Ontario, Canada
- Hôpital Gui de Chauliac — Montpellier, France
- Charité - Universitätsmedizin Berlin — Berlin, Germany
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Rome, Italy
- Hospital Txagorritxu — Vitoria-Gasteiz, Spain
- University College London Hospitals — London, United Kingdom
Full record on ClinicalTrials.gov
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