Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

Recruiting

• Conditions: Insomnia
• Interventions: Drug: Non-orexin receptor antagonist medications for insomnia; Other: No insomnia medication; Drug: Daridorexant

• Registration Number: NCT06498128
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-07-05
• Study First Posted: 2024-07-12
• Study Start: 2024-11-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2033-03
• Study Completion: 2033-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 785

Inclusion Criteria

1. Diagnosis of insomnia disorder prior to pregnancy.

2. Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.

3. One of the following:

   1. Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.
   2. Exposure to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
   3. No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.

Exclusion Criteria

• Exposure to any orexin receptor antagonist other than QUVIVIQ - including BELSOMRA® (suvorexant), DAYVIGO® (lemborexant), any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during the current pregnancy or within 5 half-lives of the respective medication prior to conception.

B) Eligibility criteria for retrospective pregnancies:

Inclusion criteria:

1. Diagnosis of insomnia disorder prior to pregnancy.
2. Pregnancy has ended.
3. Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.

Exclusion criteria:

• Exposure to any orexin receptor antagonist other than QUVIVIQ - including suvorexant, lemborexant, any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during pregnancy or within 5 half-lives of the respective medication prior to conception.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-orexin receptor antagonist medications for insomnia (Cohort B1)	Non-orexin receptor antagonist medications for insomnia	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.
No insomnia medications (Cohort B2)	No insomnia medication	Women who had no exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.
QUIVIQ (Cohort A)	Daridorexant	Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.

Primary Outcome Measures

Name	Time	Method
Major congenital malformations classified according to MACDP	Start of pregnancy up to 1 year of infant age	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.

Secondary Outcome Measures

Name	Time	Method
Pregnancy complications - number of participants with pre-eclampsia	20 weeks gestation until delivery/birth/labor	The presence of hypertension on 2 occasions at least 4 hours apart after 20 weeks gestation (in a woman with previously normal blood pressure) and proteinuria; or, in the absence of proteinuria, a new onset of hypertension accompanied by one of the following conditions: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual symptoms.
Pregnancy complications - number of participants with pregnancy-induced hypertension	20 weeks gestation until delivery/birth/labor	High blood pressure associated with pregnancy, as diagnosed by the treating healthcare provider, i.e., elevated (systolic between 120-129 mmHg and diastolic less than 80 mmHg); Stage 1 hypertension (systolic between 130-139 mmHg or diastolic between 80-89 mmHg); or Stage 2 hypertension (systolic at least 140 mmHg or diastolic at least 90 mmHg).
Pregnancy complications - number of participants with pre-term labor	Start of pregnancy up to 37 weeks gestation	Regular contractions of the uterus resulting in changes in the cervix that start before 37 weeks of pregnancy.
Pregnancy complications - number of participants with gestational diabetes	Start of pregnancy until delivery/birth/labor	Characterized by the development of carbohydrate intolerance with first onset or first recognition during pregnancy.
Pregnancy outcomes - number of participants with pregnancy outcome of elective or therapeutic pregnancy termination	Start of pregnancy until delivery/birth/labor	Any induced or voluntary fetal loss during pregnancy.
Pregnancy outcomes - number of participants with pregnancy outcome of spontaneous abortion	Start of pregnancy up to 20 weeks gestation	Loss of a fetus due to natural causes at less than 20 weeks of gestation.
Pregnancy outcomes - number of participants with pregnancy outcome of fetal death or stillbirth	20 weeks gestation up to birth	Death of a fetus at or after 20 weeks of gestation.
Pregnancy outcomes - number of participants with pregnancy outcome of live birth	37 weeks gestation up to 40 weeks gestation	Birth of a surviving neonate.
Pregnancy outcomes - number of participants with pregnancy outcome of pre-term birth	Less than 34 weeks gestation up to 37 weeks gestation	Live birth prior to 37 weeks gestation: early preterm (\< 34 weeks), late preterm (34-36 weeks), and early term (37-38 weeks).
Infant outcomes - number of infants with outcome of minor congenital malformations classified according to MACDP	Start of pregnancy up to 1 year of infant age	Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential minor congenital malformations will be evaluated by at least 3, qualified, independent teratologists using all available medical records. Classification will be based upon the teratologists' adjudication, who will be blinded to participant exposure status.
Infant outcomes - infants categorized according to size for gestational age	At birth of infant	All live births will be classified using the World Health Organization definition of birth weight, i.e., small (below the 10th percentile), appropriate (between the 10th and 90th percentile), or large (above the 90th percentile) for gestational age.
Infant outcomes - number of infants with outcome of low birth weight	At birth of infant	Birth weight of less than 2500 g; subclassified into very low birth weight (\< 1500 g) and moderately low birth weight (1500 g to 2499 g).
Infant outcomes - number of infants with outcome of infant death	Birth of infant up to 1 year of infant age	Death of a live-born infant within the first year of life; subclassified as neonatal deaths (≤ 28 days of life) and infant deaths (29 to 365 days of life).
Infant outcomes - number of infants with outcome of hospitalization for serious illness	Birth of infant up to 1 year of infant age	In-patient admissions for treatment of potentially life threatening illnesses among live-born infants within the first year of life.
Infant outcomes - postnatal growth and development - weight-for-length	Birth of infant up to 1 year of infant age	World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific weight-for-length percentiles (weight in kilograms, length in centimeters).
Infant outcomes - postnatal growth and development - head circumference-for-age	Birth of infant up to 1 year of infant age	World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific head circumference-for-age percentiles (head circumference in centimeters, age in months and years).
Infant outcomes - postnatal growth and development - length-for-age	Birth of infant up to 1 year of infant age	World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific length-for-age percentiles (length in centimeters, age in months and years).
Infant outcomes - postnatal growth and development - weight-for-age	Birth of infant up to 1 year of infant age	World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific weight-for-age percentiles (weight in kilograms, age in months and years).

Trial Locations

Locations (7)

IQVIA US Office; 🇺🇸 Durham, North Carolina, United States

Jodha Tishon; 🇨🇦 Toronto, Ontario, Canada

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Azienda Ospedaliera Universitaria Policlinico Tor Vergata; 🇮🇹 Rome, Italy

Hospital Txagorritxu; 🇪🇸 Vitoria, Spain

University College London Hospitals; 🇬🇧 London, United Kingdom