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Purpose

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

Eligibility

Eligible Ages
All ages
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA Pregnant women with a diagnosis of narcolepsy or OSA
  • Drug: Sunosi (solriamfetol)
    Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
Cohort 2: Unexposed participants with narcolepsy or OSA Pregnant women with a diagnosis of narcolepsy or OSA
  • Other: No treatment
    No treatment
Cohort 3: Other-exposed participants with narcolepsy or OSA Pregnant women with a diagnosis of narcolepsy or OSA
  • Drug: Other prescription wake-promoting medications or stimulants
    Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.
Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA Pregnant women without a diagnosis of narcolepsy or OSA
  • Drug: Sunosi (solriamfetol)
    Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
Cohort 5: Other-exposed participants without narcolepsy or OSA Pregnant women without a diagnosis of narcolepsy or OSA
  • Drug: Other prescription wake-promoting medications or stimulants
    Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.

Recruiting Locations

Evidera, a PPD business unit
Morrisville, North Carolina 27560

PPD, Inc.
Wilmington, North Carolina 28401

More Details

Status
Recruiting
Sponsor
Axsome Therapeutics, Inc.

Study Contact

Study Director
1-877-283-6220
sunosipregnancyregistry@ppd.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.