NCT06498128 Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
| NCT ID | NCT06498128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Idorsia Pharmaceuticals Ltd. |
| Condition | Insomnia |
| Study Type | OBSERVATIONAL |
| Enrollment | 785 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2033-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 785 participants in total. It began in 2024-11-21 with a primary completion date of 2033-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
A) Eligibility criteria for prospective pregnancies: Inclusion Criteria: 1. Diagnosis of insomnia disorder prior to pregnancy. 2. Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known. 3. One of the following: 1. Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception. 2. 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. 3. No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception. Exclusion Criteria: * 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: 1. Diagnosis of insomnia disorder prior to pregnancy. 2. Pregnancy has ended. 3. 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.
Contact & Investigator
Clinical Trials Study Director
STUDY DIRECTOR
Idorsia Pharmaceuticals Ltd.
Frequently Asked Questions
Who can join the NCT06498128 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 50 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06498128 currently recruiting?
Yes, NCT06498128 is actively recruiting participants. Contact the research team at idorsiaclinicaltrials@idorsia.com for enrollment information.
Where is the NCT06498128 trial being conducted?
This trial is being conducted at Durham, United States, Toronto, Canada, Montpellier, France, Berlin, Germany and 3 additional locations.
Who is sponsoring the NCT06498128 clinical trial?
NCT06498128 is sponsored by Idorsia Pharmaceuticals Ltd.. The principal investigator is Clinical Trials Study Director at Idorsia Pharmaceuticals Ltd.. The trial plans to enroll 785 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.