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NCT06413420 Clinical Trial

SUNOSI® (Solriamfetol) Pregnancy Registry

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06413420
Other study ID # JZP110-402
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 31, 2019
Est. completion date September 2029

Study information
Verified date May 2024
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone 1-877-283-6220
Email sunosipregnancyregistry@ppd.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1731
Est. completion date September 2029
Est. primary completion date September 2029
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Sunosi (solriamfetol)
Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
• 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
Country Name City State
United States Evidera, a PPD business unit Morrisville North Carolina
United States PPD, Inc. Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term Safety Baseline up to 12 months after pregnancy outcome
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