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NCT06413420 · ClinicalTrials.gov registry record

SUNOSI® (Solriamfetol) Pregnancy Registry

A clinical trial of Obstructive Sleep Apnea and Narcolepsy, sponsored by Axsome Therapeutics.

Recruiting
Registry status
1,731
Enrollment target
2
Study locations

NCT06413420 is a study of Obstructive Sleep Apnea and Narcolepsy that is actively recruiting participants, run by Axsome Therapeutics. The registered enrollment target is 1,731 participants, above the 210-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (724% higher). The trial reports 2 study locations across 1 state.

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The verdict

NCT06413420, a study of Obstructive Sleep Apnea and Narcolepsy, is actively recruiting participants, sponsored by Axsome Therapeutics.

RECRUITING
Registry status
1,731 participants
Enrollment target
2
Study locations

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

28 total trials

What the Registry Record Tells You About NCT06413420

The ClinicalTrials.gov registry entry for NCT06413420 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,731 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 210-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (724% higher). The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.

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.

NCT06413420 reports 2 study locations spanning 1 distinct geographic area - top geographies include North Carolina.

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.

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).

Who is sponsoring clinical trial NCT06413420?

This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.