NCT06413420 SUNOSI® (Solriamfetol) Pregnancy Registry
| NCT ID | NCT06413420 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Axsome Therapeutics, Inc. |
| Condition | Narcolepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,731 participants |
| Start Date | 2019-07-31 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,731 participants in total. It began in 2019-07-31 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).
Eligibility Criteria
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 or in the relevant exposure window before conception * Resident of the US or Canada * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06413420 clinical trial?
This trial is open to female participants only, studying Narcolepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06413420 currently recruiting?
Yes, NCT06413420 is actively recruiting participants. Contact the research team at sunosipregnancyregistry@ppd.com for enrollment information.
Where is the NCT06413420 trial being conducted?
This trial is being conducted at Morrisville, United States, Wilmington, United States.
Who is sponsoring the NCT06413420 clinical trial?
NCT06413420 is sponsored by Axsome Therapeutics, Inc.. The trial plans to enroll 1,731 participants.