NCT06413420Recruiting

SUNOSI® (Solriamfetol) Pregnancy Registry

Axsome Therapeutics, Inc.

Start Date

7/31/2019

Completion Date

9/1/2029

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).

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DRUG

Sunosi (solriamfetol)

DRUG

Other prescription wake-promoting medications or stimulants

OTHER

No treatment

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Conditions

NarcolepsyObstructive Sleep ApneaPregnant Women and Their Offspring

Locations

Evidera, a PPD business unit

Morrisville, North Carolina 27560

United States

PPD, Inc.

Wilmington, North Carolina 28401

United States