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NCT06393504 · ClinicalTrials.gov registry record
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
A clinical trial of Insomnia Disorder, sponsored by Idorsia Pharmaceuticals.
- Active
- Registry status
- 2,095
- Enrollment target
- 1
- Study location
NCT06393504: Active study of Insomnia Disorder, sponsored by Idorsia Pharmaceuticals.
NCT06393504 is a study of Insomnia Disorder that is active but no longer recruiting, run by Idorsia Pharmaceuticals. The registered enrollment target is 2,095 participants, above the 213-participant average among 8 other Insomnia Disorder trials with a reported enrollment target (884% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06393504, a study of Insomnia Disorder, is active but no longer recruiting, sponsored by Idorsia Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- 2,095 participants
- Enrollment target
- 1
- Study location
Study Summary
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Daridorexant
- OTHER No insomnia medication
- DRUG Non-orexin receptor antagonist insomnia medication
Study Locations (1)
Delaware
- Carelon Research - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,095 participants |
| Start Date | 2023-11-30 |
| Est. Completion | 2028-04 |
What the registry record for NCT06393504 still lists
NCT06393504 is an observational study that tracks outcomes without assigning an intervention. Its 2,095 participants enrollment target places it among the larger protocols in the corpus, above the 213-participant average among 8 other Insomnia Disorder trials with a reported enrollment target (884% higher).
The record links to 1 condition, with Insomnia Disorder appearing as the primary indexed condition, and to 3 interventions - of which Daridorexant is the first listed.
NCT06393504 reports a single indexed study location in Delaware.
Frequently Asked Questions
What is clinical trial NCT06393504 about?
NCT06393504 is a clinical study titled "Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)". Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
What is the current status of trial NCT06393504?
This trial is currently active not recruiting. The enrollment target is 2,095 participants. The study started on 2023-11-30. Estimated completion is 2028-04.
What conditions does trial NCT06393504 study?
This clinical trial studies the following conditions: Insomnia Disorder.
What interventions are being tested in trial NCT06393504?
The interventions under investigation include: Daridorexant (DRUG), No insomnia medication (OTHER), Non-orexin receptor antagonist insomnia medication (DRUG).
Who is sponsoring clinical trial NCT06393504?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06393504 being conducted?
This trial has 1 study location across Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06393504's enrollment target sits among peer trials
2,095 1st of 8 higher than 8 of 8 other Insomnia Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
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Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
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Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study
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A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia
COMPLETED · Phase 4
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