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

Last updated: December 13, 2024
Sponsor: Idorsia Pharmaceuticals Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Treatment

Daridorexant

No insomnia medication

Non-orexin receptor antagonist medications for insomnia

Clinical Study ID

NCT06498128
ID-078A403
1000000033
  • Ages 15-50
  • Female

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.

Eligibility Criteria

Inclusion

A) Eligibility criteria for prospective pregnancies:

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:

  4. Exposure to QUVIVIQ at any time during the current pregnancy or within 5half-lives prior to conception.

  5. Exposure to other, non-orexin receptor antagonist medications for insomniaduring pregnancy or within 5 half-lives of the respective insomnia medicationprior to conception.

  6. No exposure to any insomnia medication during pregnancy and within 5 half-livesof any insomnia medication taken prior to conception.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 785
Treatment Group(s): 3
Primary Treatment: Daridorexant
Phase:
Study Start date:
November 21, 2024
Estimated Completion Date:
March 31, 2033

Connect with a study center

  • Jodha Tishon

    Toronto, Ontario
    Canada

    Site Not Available

  • Hôpital Gui de Chauliac

    Montpellier,
    France

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome,
    Italy

    Site Not Available

  • Hospital Txagorritxu

    Vitoria,
    Spain

    Site Not Available

  • University College London Hospitals

    London,
    United Kingdom

    Site Not Available

  • IQVIA

    Boston, Massachusetts 02210
    United States

    Site Not Available

  • IQVIA US Office

    Durham, North Carolina 27703
    United States

    Active - Recruiting

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