SUNOSI® (Solriamfetol) Pregnancy Registry

Last updated: May 9, 2024
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Narcolepsy

Sleep Apnea Syndromes

Treatment

Other prescription wake-promoting medications or stimulants

No treatment

Sunosi (solriamfetol)

Clinical Study ID

NCT06413420
JZP110-402
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women of any age

  • Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol orother wake promoting medications or stimulants during pregnancy

  • Resident of a country where solriamfetol is available for the treatment of excessivedaytime 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

Exclusion Criteria:

  • Occurrence of pregnancy outcome prior to first contact with the registrycoordination center (RCC)

  • Inclusion of a prior pregnancy in the main analysis population

Study Design

Total Participants: 1731
Treatment Group(s): 3
Primary Treatment: Other prescription wake-promoting medications or stimulants
Phase:
Study Start date:
July 31, 2019
Estimated Completion Date:
September 30, 2029

Study Description

The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and risks of exposure during pregnancy and make informed treatment decisions.

The study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected.

Connect with a study center

  • Evidera, a PPD business unit

    Morrisville, North Carolina 27560
    United States

    Active - Recruiting

  • PPD, Inc.

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

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