Actively Recruiting
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Led by Idorsia Pharmaceuticals Ltd. · Updated on 2025-12-02
785
Participants Needed
7
Research Sites
431 weeks
Total Duration
On this page
Sponsors
I
Idorsia Pharmaceuticals Ltd.
Lead Sponsor
I
IQVIA Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
CONDITIONS
Official Title
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of insomnia disorder prior to pregnancy
- Pregnancy is ongoing and outcome of pregnancy is not known, or pregnancy has ended (for retrospective pregnancies)
- Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception, or
- Exposure to other non-orexin receptor antagonist insomnia medications during pregnancy or within 5 half-lives prior to conception, or
- No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception (for prospective pregnancies)
- For retrospective pregnancies, exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception
You will not qualify if you...
- Exposure to any orexin receptor antagonist other than QUVIVIQ (including suvorexant, lemborexant, or any newly approved or investigational orexin receptor antagonist) during the current pregnancy or within 5 half-lives prior to conception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
IQVIA US Office
Durham, North Carolina, United States, 27703
Actively Recruiting
2
Jodha Tishon
Toronto, Ontario, Canada
Not Yet Recruiting
3
Hôpital Gui de Chauliac
Montpellier, France
Not Yet Recruiting
4
Charité - Universitätsmedizin Berlin
Berlin, Germany
Not Yet Recruiting
5
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy
Not Yet Recruiting
6
Hospital Txagorritxu
Vitoria-Gasteiz, Spain
Not Yet Recruiting
7
University College London Hospitals
London, United Kingdom
Not Yet Recruiting
Research Team
C
Clinical Trial Information USA
CONTACT
C
Clinical Trial Information Europe
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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