SUNOSI® (Solriamfetol) Pregnancy Registry

May 9, 2024 updated by: Axsome Therapeutics, Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1731

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • Evidera, a PPD business unit
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • PPD, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include pregnant women of any age who reside in a country where solriamfetol is available for the treatment of narcolepsy or OSA, provide consent to participate as well as medical releases for their healthcare providers (HCPs) to provide data to the registry, and meet the criteria for inclusion into 1 of the 5 cohorts.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
Drug: Sunosi (solriamfetol)
Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
Cohort 2: Unexposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
Other: No treatment
No treatment
Cohort 3: Other-exposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
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.
Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA
Pregnant women without a diagnosis of narcolepsy or OSA
Drug: Sunosi (solriamfetol)
Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
Cohort 5: Other-exposed participants without narcolepsy or OSA
Pregnant women without a diagnosis of narcolepsy or OSA
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long-term Safety
Time Frame: Baseline up to 12 months after pregnancy outcome
Baseline up to 12 months after pregnancy outcome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2019

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JZP110-402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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