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Non-orexin receptor antagonist medications for insomnia (Cohort B1) for Insomnia

N/A
Waitlist Available
Research Sponsored by Idorsia Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth of infant up to 1 year of infant age
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth of infant up to 1 year of infant age
This trial's timeline: 3 weeks for screening, Varies for treatment, and birth of infant up to 1 year of infant age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Major congenital malformations classified according to MACDP
Secondary study objectives
Infant outcomes - infants categorized according to size for gestational age
Infant outcomes - number of infants with outcome of hospitalization for serious illness
Infant outcomes - number of infants with outcome of infant death
+15 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: QUIVIQ (Cohort A)Experimental Treatment1 Intervention
Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
Group II: Non-orexin receptor antagonist medications for insomnia (Cohort B1)Experimental Treatment1 Intervention
Women exposed to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
Group III: No insomnia medications (Cohort B2)Experimental Treatment1 Intervention
Women who had no exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daridorexant
2020
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor
121 Previous Clinical Trials
35,168 Total Patients Enrolled
2 Trials studying Insomnia
250 Patients Enrolled for Insomnia
Iqvia Pty LtdIndustry Sponsor
112 Previous Clinical Trials
172,848 Total Patients Enrolled
Clinical Trials Study DirectorStudy DirectorIdorsia Pharmaceuticals Ltd.
3 Previous Clinical Trials
2,157 Total Patients Enrolled
~523 spots leftby Mar 2033
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