Clinical trial NCT06393504: Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Official title: Healthcare Claims Database Study to Provide Safety Information on Maternal, Fetal and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) During Pregnancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Insomnia Disorder
Keywords: Pregnancy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Carelon Research
First posted: 2024-05-01
Enrollment: 2095
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with an end of pregnancy event between 1 May 2022 and 31 May 2027 (called the "intake period") and a diagnosis of insomnia disorder are included in the base cohort, from which the exposure- and outcome-specific analytic cohorts will be created.

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

Detailed description: This is a longitudinal observational cohort study using an electronic database of healthcare claims data. Safety information will be retrospectively collected from the database and pre-specified diagnostic codes will be used to identify pregnancy and infant outcomes. The study will include two phases, a patient accrual phase (Phase 1) and an analysis phase (Phase 2).

Descriptive statistics will be conducted to characterize the patient population and to support the interpretation of comparative analyses. Comparative analyses will be performed to estimate the effect of QUVIVIQ exposure during pregnancy on the study outcomes. Approximately 419 mother-infant pairs with exposure to QUVIVIQ and 1676 mother-infant pairs with exposure to non-orexin receptor antagonist insomnia medication are expected with a 1:4 ratio of exposed:active comparator patients.

Analysis of the prevalence of each specific pregnancy or infant outcome will comprise: (1) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia exposed to any non-orexin receptor antagonist insomnia medication during or shortly prior to pregnancy (active comparator group); (2) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia unexposed to any insomnia medication during or shortly prior to pregnancy (unexposed comparator group).

Eligibility criteria: 1. Evidence of a singleton end of pregnancy event during the intake period.
2. ≥ 1 insomnia diagnosis during the period which begins 12 months prior to the date of conception and ends at the end of pregnancy.
3. Date of conception ≥ 42 weeks before the end of the intake period.
4. Age 15 to 50 years at the date of conception.
5. Continuous medical and pharmacy insurance coverage during the period which begins 6 months prior to the date of conception and ends at the end of pregnancy.
6. No dispensing of known or suspected teratogenic medications during the period which begins 5 half lives of that medication prior to the date of conception and ends at the end of pregnancy.
7. No exposure to other orexin receptor antagonists during the exposure period, i.e., suvorexant, lemborexant, and any orexin receptor antagonists newly approved during the intake period.

Primary outcomes:
measure: Prevalence of major congenital malformations (MCMs)
timeFrame: From May 2022 to April 2028 (6 years)
Secondary outcomes:
measure: Prevalence of spontaneous abortions (SABs)
timeFrame: From May 2022 to April 2028 (6 years)
measure: Prevalence of stillbirths (SBs)
timeFrame: From May 2022 to April 2028 (6 years)
measure: Prevalence of small for gestational age infants (SGAs)
timeFrame: From May 2022 to April 2028 (6 years)
measure: Prevalence of preterm births (PTBs)
timeFrame: From May 2022 to April 2028 (6 years)
measure: Prevalence of induced abortions (IABs)
timeFrame: From May 2022 to April 2028 (6 years)
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Carelon Research
state: Delaware
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials Study Director
role: STUDY_DIRECTOR
References: