SUNOSI® (Solriamfetol) Pregnancy Registry

Axsome Therapeutics, Inc.1,731 enrolled

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).

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.

Study Type

OBSERVATIONAL

Enrollment

1,731

Conditions

Narcolepsy Obstructive Sleep Apnea Pregnant Women and Their Offspring

Interventions

Sunosi (solriamfetol)DRUG

Exposure to at least 1 dose of solriamfetol at any time during pregnancy.

Other prescription wake-promoting medications or stimulantsDRUG

Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.

No treatmentOTHER

No treatment

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (2)

Evidera, a PPD business unit

Morrisville, North Carolina, United States

RECRUITING

PPD, Inc.

Wilmington, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Long-term Safety

Time frame: Baseline up to 12 months after pregnancy outcome

Central Contacts

Study Director

CONTACT

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

Data from ClinicalTrials.gov

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