SUNOSI® (Solriamfetol) Pregnancy Registry

Description

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

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Study Overview

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Study Details

Study overview

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).

SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring

SUNOSI® (Solriamfetol) Pregnancy Registry

Condition
Narcolepsy
Intervention / Treatment

-

Contacts and Locations

Morrisville

Evidera, a PPD business unit, Morrisville, North Carolina, United States, 27560

Wilmington

PPD, Inc., Wilmington, North Carolina, United States, 28401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Axsome Therapeutics, Inc.,

Study Record Dates

2029-09