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SUNOSI® (Solriamfetol) Pregnancy Registry

NCT06413420 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1731

Last updated 2024-05-14

No results posted yet for this study

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).

Conditions

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

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2029-09-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06413420 on ClinicalTrials.gov