SUNOSI® (Solriamfetol) Pregnancy Registry

Axsome Therapeutics

Status: Enrolling

Conditions: Obstructive Sleep Apnea; Pregnant Women and Their Offspring; Narcolepsy

Treatments: Other: No treatment; Drug: Other prescription wake-promoting medications or stimulants; Drug: Sunosi (solriamfetol)

Study type: Observational

Funder types: Industry

Identifiers

NCT06413420

JZP110-402

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,731 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

1,731 participants in 5 patient groups

Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA

Description:

Pregnant women with a diagnosis of narcolepsy or OSA

Treatment:

Drug: Sunosi (solriamfetol)

Cohort 2: Unexposed participants with narcolepsy or OSA

Description:

Pregnant women with a diagnosis of narcolepsy or OSA

Treatment:

Other: No treatment

Cohort 3: Other-exposed participants with narcolepsy or OSA

Description:

Pregnant women with a diagnosis of narcolepsy or OSA

Treatment:

Drug: Other prescription wake-promoting medications or stimulants

Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA

Description:

Pregnant women without a diagnosis of narcolepsy or OSA

Treatment:

Drug: Sunosi (solriamfetol)

Cohort 5: Other-exposed participants without narcolepsy or OSA

Description:

Pregnant women without a diagnosis of narcolepsy or OSA

Treatment:

Drug: Other prescription wake-promoting medications or stimulants