SUNOSI® (Solriamfetol) Pregnancy Registry
The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).
Conditions:
🦠 Narcolepsy 🦠 Obstructive Sleep Apnea 🦠 Pregnant Women and Their Offspring
🗓️ Study Start (Actual) 31 July 2019
🗓️ Primary Completion (Estimated) September 2029
✅ Study Completion (Estimated) September 2029
👥 Enrollment (Estimated) 1731
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Morrisville, North Carolina, United States
📍 Wilmington, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Pregnant women of any age
    • * Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy
    • * Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA
    • * Provides written informed consent to participate in the study
    • * Authorization for her HCP(s) to provide data to the registry

    Exclusion Criteria:

    • * Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
    • * Inclusion of a prior pregnancy in the main analysis population
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 May 2024
  • First Submitted that Met QC Criteria 9 May 2024
  • First Posted 14 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 May 2024
  • Last Update Posted 14 May 2024
  • Last Verified May 2024