Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT06393504
Status
Active Not Recruiting

Conditions

  • Insomnia Disorder

Eligibility Criteria

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

Interventions

  • Daridorexant — DRUG
    Daridorexant received during or shortly prior to pregnancy.
  • Non-orexin receptor antagonist insomnia medication — DRUG
    Non-orexin receptor antagonist insomnia medication received during or shortly prior to pregnancy.
  • No insomnia medication — OTHER
    No insomnia medication received during or shortly prior to pregnancy.

Study Details

Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy

Key Dates

Start date
Nov 30, 2023
Status verified
Apr 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
2,095 participants (estimated)

Arms

  • Arm: QUVIVIQ-exposed group
    Pregnant women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to date of conception.
  • Arm: Active comparator group
    Pregnant women with insomnia exposed to non-orexin receptor antagonist insomnia medications during pregnancy or within 5 half-lives of the respective insomnia medication prior to date of conception.
  • Arm: Unexposed comparator group
    Pregnant women with insomnia unexposed to insomnia medications during pregnancy and within 5 half-lives of any insomnia medication taken prior to date of conception.

Primary Outcome Measure

Prevalence of major congenital malformations (MCMs) [ Time Frame: From May 2022 to April 2028 (6 years) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Carelon ResearchWilmingtonDelaware19801-

Find similar trials in Wilmington, DE

By research site
Carelon Research· Wilmington, DE

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