SUNOSI® (Solriamfetol) Pregnancy Registry

Recruiting

• Conditions: Narcolepsy; Obstructive Sleep Apnea; Pregnant Women and Their Offspring
• Interventions: Drug: Sunosi (solriamfetol); Other: No treatment; Drug: Other prescription wake-promoting medications or stimulants

• Registration Number: NCT06413420
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief 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.

Study Timeline

• Study Start: 2019-07-31
• Status Verified: 2024-05
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Study First Posted: 2024-05-14
• Last Update Posted: 2024-05-14
• Primary Completion: 2029-09
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1731

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA	Sunosi (solriamfetol)	Pregnant women with a diagnosis of narcolepsy or OSA
Cohort 2: Unexposed participants with narcolepsy or OSA	No treatment	Pregnant women with a diagnosis of narcolepsy or OSA
Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA	Sunosi (solriamfetol)	Pregnant women without a diagnosis of narcolepsy or OSA
Cohort 3: Other-exposed participants with narcolepsy or OSA	Other prescription wake-promoting medications or stimulants	Pregnant women with a diagnosis of narcolepsy or OSA
Cohort 5: Other-exposed participants without narcolepsy or OSA	Other prescription wake-promoting medications or stimulants	Pregnant women without a diagnosis of narcolepsy or OSA

Primary Outcome Measures

Name	Time	Method
Long-term Safety	Baseline up to 12 months after pregnancy outcome

Trial Locations

Locations (2)

Evidera, a PPD business unit; 🇺🇸 Morrisville, North Carolina, United States

PPD, Inc.; 🇺🇸 Wilmington, North Carolina, United States