SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
Overview
- Phase
- Not Applicable
- Intervention
- Sunosi (solriamfetol)
- Conditions
- Narcolepsy
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 1731
- Locations
- 2
- Primary Endpoint
- Long-term Safety
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
Intervention: Sunosi (solriamfetol)
Cohort 2: Unexposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
Intervention: No treatment
Cohort 3: Other-exposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
Intervention: Other prescription wake-promoting medications or stimulants
Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA
Pregnant women without a diagnosis of narcolepsy or OSA
Intervention: Sunosi (solriamfetol)
Cohort 5: Other-exposed participants without narcolepsy or OSA
Pregnant women without a diagnosis of narcolepsy or OSA
Intervention: Other prescription wake-promoting medications or stimulants
Outcomes
Primary Outcomes
Long-term Safety
Time Frame: Baseline up to 12 months after pregnancy outcome