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NCT Number: NCT06413420

SUNOSI® (Solriamfetol) Pregnancy Registry

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).

Recruiting

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Key information

Conditions

Narcolepsy Apnea Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Obstructive Sleep Apnea Pregnant Women and Their Offspring Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

Female

Study type

Observational

Primary location

Evidera, a PPD business unit, Morrisville, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunosi (solriamfetol)

Drug

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

Other prescription wake-promoting medications or stimulants

Drug

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

No treatment

Other

No treatment

Primary outcomes

  1. Long-term Safety

    Time frame: Baseline up to 12 months after pregnancy outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

1-877-283-6220

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
May 14, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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