Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing Sunosi (solriamfetol) for Narcolepsy

The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, watch-and-measure (no experimental treatment required) study to measure the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).

Official registry: https://clinicaltrials.gov/study/NCT06413420 · Axsome Therapeutics, Inc. · enrollment listed as 1,731

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 1,731 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment

Primary outcome (registry wording): Long-term Safety

Who it is for (from inclusion criteria)

  • Women only
  • 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
  • Authorization for her HCP(s) to provide data to the registry

Public study contact (from the registry)

Study Director

1-877-283-6220

sunosipregnancyregistry@ppd.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea

Background: Obstructive sleep apnea (OSA) occurs when the blockage of the airway causes a person to stop breathing involuntarily for 10 seconds or more throughout the night during sleep. Pediatric OSA can be especially concerning and can have long-term effects.

NCT05052216 · Official ClinicalTrials.gov record · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

RecruitingNot a traditional drug phaseSan Diego, California
Not a traditional drug phase: Positive Airway Pressure Device for Post Traumatic Stress Disorder

Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings.

NCT05156112 · Official ClinicalTrials.gov record · VA Office of Research and Development

RecruitingNot a traditional drug phaseBeijing
Not a traditional drug phase: Level III portable sleep study for Sleep Apnea

The investigators propose a prospective, watch-and-measure (no experimental treatment required) study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated.

NCT05595200 · Official ClinicalTrials.gov record · Chinese Pulmonary Vascular Disease Research Group

FAQ about this NCT record

Is NCT06413420 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06413420?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06413420?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary