Clinical Trials Logo
  1. Home
  2. Insomnia Disorder
  3. NCT06393504

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 Summary

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

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06393504
Study type Observational
Source Idorsia Pharmaceuticals Ltd.
Contact
Status Active, not recruiting
Phase
Start date November 30, 2023
Completion date April 2028
View Details
See also
  Status Clinical Trial Phase
Completed NCT00821041 - Internet-based Treatment for Chronic Insomnia Phase 2
Completed NCT03727438 - Provider Supported Self-Help Cognitive Behavioral Therapy for Insomnia (Tele-Self CBTI) N/A
Recruiting NCT03633305 - Optimization of Insomnia Treatment in Primary Care N/A
Completed NCT04616157 - Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial N/A
Completed NCT03679884 - Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep Phase 3
Completed NCT02839200 - Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder Phase 2
Recruiting NCT04752254 - Investigating Racing Thoughts in Patients With Insomnia Disorder
Completed NCT05558865 - Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia) N/A
Completed NCT05541055 - Digital CBT-I for Insomnia Disorder N/A
Completed NCT02841709 - Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder Phase 2
Completed NCT03328585 - Telemedicine vs. In-person Delivery of Cognitive Behavioral Treatment of Insomnia: a Mixed Methods Analysis N/A
Completed NCT02952820 - Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2) Phase 3
Recruiting NCT05408078 - Become Your Own SLEEPexpert: a Behavioral Treatment Program for Insomnia in Patients With Psychiatric Disorders N/A
Recruiting NCT05780983 - Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults N/A
Completed NCT03575104 - Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep Phase 3
Not yet recruiting NCT06279286 - Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder Phase 1/Phase 2
Terminated NCT02571595 - A Sleep Program to Improve Sleep Quality in People With HIV N/A
Completed NCT00984698 - A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD) N/A
Recruiting NCT05780177 - Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder N/A
Completed NCT05805527 - Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study