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RECRUITING

SUNOSI® (Solriamfetol) Pregnancy Registry

NCT06413420 · View on ClinicalTrials.gov ↗

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).

Interventions

  • DRUG Sunosi (solriamfetol)
  • DRUG Other prescription wake-promoting medications or stimulants
  • OTHER No treatment

Study Locations (2)

North Carolina

  • Evidera, a PPD business unit — Morrisville
  • PPD, Inc. — Wilmington

Trial Details

FieldValue
Enrollment Target 1,731 participants
Start Date 2019-07-31
Est. Completion 2029-09

Sponsor

Axsome Therapeutics

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06413420

The ClinicalTrials.gov registry entry for NCT06413420 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,731 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 3 interventions — of which Sunosi (solriamfetol) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06413420 reports 2 study locations spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06413420 about?

NCT06413420 is a clinical study titled "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).

What is the current status of trial NCT06413420?

This trial is currently recruiting. The enrollment target is 1,731 participants. The study started on 2019-07-31. Estimated completion is 2029-09.

What conditions does trial NCT06413420 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea, Narcolepsy, Pregnant Women and Their Offspring. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06413420?

The interventions under investigation include: Sunosi (solriamfetol) (DRUG), Other prescription wake-promoting medications or stimulants (DRUG), No treatment (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06413420?

This trial is sponsored by Axsome Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06413420 being conducted?

This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial