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RECRUITING
NCT06413420

SUNOSI® (Solriamfetol) Pregnancy Registry

Sponsor: Axsome Therapeutics, Inc.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1731

Start Date

2019-07-31

Completion Date

2029-09

Last Updated

2024-05-14

Healthy Volunteers

No

Interventions

DRUG

Sunosi (solriamfetol)

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

DRUG

Other 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.

OTHER

No treatment

No treatment

Locations (2)

Evidera, a PPD business unit

Morrisville, North Carolina, United States

PPD, Inc.

Wilmington, North Carolina, United States