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

Insomnia Disorder Clinical Trial

Official title:

Healthcare Claims Database Study to Provide Safety Information on Maternal, Fetal and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) During Pregnancy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06393504
• Other study ID #: ID-078A404
• Status: Active, not recruiting
• Start date: November 30, 2023
• Est. completion date: April 2028

Study information

• Verified date: April 2024
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2095
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Daridorexant
Daridorexant received during or shortly prior to pregnancy.
• Non-orexin receptor antagonist insomnia medication
Non-orexin receptor antagonist insomnia medication received during or shortly prior to pregnancy.

Other:
• No insomnia medication
No insomnia medication received during or shortly prior to pregnancy.

Locations

Country	Name	City	State
United States	Carelon Research	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.	Carelon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of major congenital malformations (MCMs)	MCMs will be identified as pre-specified diagnostic codes for malformations included in the National Birth Defects Prevention Network's birth defects descriptions (identified through maternal and infant claims).; MCMs with etiologies presumed not to be associated with drug exposure, such as chromosomal abnormalities, genetic syndromes, prematurity-related defects, and positional effects, will be excluded from the definition of MCMs.	From May 2022 to April 2028 (6 years)
Secondary	Prevalence of spontaneous abortions (SABs)	An SAB is defined as the loss of an embryo before 20 gestational weeks (identified through maternal claims).	From May 2022 to April 2028 (6 years)
Secondary	Prevalence of stillbirths (SBs)	An SB is defined as the loss of a fetus at or after 20 gestational weeks (identified through maternal claims).	From May 2022 to April 2028 (6 years)
Secondary	Prevalence of small for gestational age infants (SGAs)	SGA is defined as birth weight less than or equal to the tenth percentile for gestational age (identified through maternal and infant claims).	From May 2022 to April 2028 (6 years)
Secondary	Prevalence of preterm births (PTBs)	PTB is defined as a live birth before 37 gestational weeks (identified through maternal and infant claims).	From May 2022 to April 2028 (6 years)
Secondary	Prevalence of induced abortions (IABs)	An IAB is defined as the elective termination of the pregnancy (identified through maternal claims).	From May 2022 to April 2028 (6 years)