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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT06498128
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant — DRUG
    Dosing and treatment duration of QUVIVIQ as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
  • Non-orexin receptor antagonist medications for insomnia — DRUG
    Dosing and treatment duration of non-orexin receptor antagonist medications for insomnia as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
  • No insomnia medication — OTHER
    No insomnia medication was administered.

Study Details

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 Dates

Start date
Nov 21, 2024
Status verified
Dec 2025
Primary completion
Mar 31, 2033
Completion
Mar 31, 2033

Study Design

Enrollment
785 participants (estimated)

Arms

  • Arm: QUIVIQ (Cohort A)
    Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
  • Arm: Non-orexin receptor antagonist medications for insomnia (Cohort B1)
    Women exposed to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
  • Arm: No insomnia medications (Cohort B2)
    Women who had no exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.

Primary Outcome Measure

Major congenital malformations classified according to MACDP [ Time Frame: Start of pregnancy up to 1 year of infant age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
IQVIA US OfficeDurhamNorth Carolina27703-

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IQVIA US Office· Durham, NC

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