RecruitingNCT06413420

SUNOSI® (Solriamfetol) Pregnancy Registry

SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring


Sponsor

Axsome Therapeutics, Inc.

Enrollment

1,731 participants

Start Date

Jul 31, 2019

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying No treatment, a drug called Other prescription wake-promoting medications or stimulants, and others for people with narcolepsy, obstructive sleep apnea, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include women.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSunosi (solriamfetol)

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

DRUGOther prescription wake-promoting medications or stimulants

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

OTHERNo treatment

No treatment


Locations(2)

Evidera, a PPD business unit

Morrisville, North Carolina, United States

PPD, Inc.

Wilmington, North Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT06413420


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