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NCT06498128 · ClinicalTrials.gov registry record
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
A clinical trial of Insomnia, sponsored by Idorsia Pharmaceuticals.
- Recruiting
- Registry status
- 785
- Enrollment target
- 7
- Study locations
NCT06498128: Recruiting study of Insomnia, sponsored by Idorsia Pharmaceuticals.
NCT06498128 is a study of Insomnia that is actively recruiting participants, run by Idorsia Pharmaceuticals. The registered enrollment target is 785 participants, above the 165-participant average among 151 other Insomnia trials with a reported enrollment target (376% higher). The trial reports 7 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06498128, a study of Insomnia, is actively recruiting participants, sponsored by Idorsia Pharmaceuticals.
- RECRUITING
- Registry status
- 785 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Primary Outcome
Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential major congenital malformations identified by the participant's or the infant's healthcare providers will be evaluated by a qualified, independent committee of at least 3 teratologists using all available medical records. Classification will be based upon the teratologists' adjudication, who will be blinded to participant exposure status.
Conditions Studied
Interventions
- DRUG Daridorexant
- DRUG Non-orexin receptor antagonist medications for insomnia
- OTHER No insomnia medication
Study Locations (7)
Other
- Hôpital Gui de Chauliac - Montpellier
- Charité - Universitätsmedizin Berlin - Berlin
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata - Rome
- Hospital Txagorritxu - Vitoria-Gasteiz
- University College London Hospitals - London
North Carolina
- IQVIA US Office - Durham
Ontario
- Jodha Tishon - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 785 participants |
| Start Date | 2024-11-21 |
| Est. Completion | 2033-03 |
What NCT06498128 shows while recruiting
NCT06498128 is an observational study that tracks outcomes without assigning an intervention. The registered 785 participants enrollment target is mid-sized for trials with a published cap, above the 165-participant average among 151 other Insomnia trials with a reported enrollment target (376% higher).
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 3 interventions - of which Daridorexant is the first listed.
NCT06498128 lists 7 locations in 3 states (Other, North Carolina, Ontario).
Frequently Asked Questions
What is clinical trial NCT06498128 about?
NCT06498128 is a clinical study titled "Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®". This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
What is the current status of trial NCT06498128?
This trial is currently recruiting. The enrollment target is 785 participants. The study started on 2024-11-21. Estimated completion is 2033-03.
What conditions does trial NCT06498128 study?
This clinical trial studies the following conditions: Insomnia.
What interventions are being tested in trial NCT06498128?
The interventions under investigation include: Daridorexant (DRUG), Non-orexin receptor antagonist medications for insomnia (DRUG), No insomnia medication (OTHER).
Who is sponsoring clinical trial NCT06498128?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06498128 being conducted?
This trial has 7 study locations across North Carolina, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
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 NCT06498128's enrollment target sits among peer trials
785 5th of 151 higher than 147 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia 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
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