RECRUITING

SUNOSI® (Solriamfetol) Pregnancy Registry

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Conditions

NarcolepsyObstructive Sleep ApneaPregnant Women and Their OffspringSolriamfetolSUNOSIAxsomeNon-stimulant therapyDopamine norepinephrine reuptake inhibitorPregnancy outcomesInfant outcomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2019-07-31
Study Completion:2029-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06413420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women of any age
  2. * Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy
  3. * Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA
  4. * Provides written informed consent to participate in the study
  5. * Authorization for her HCP(s) to provide data to the registry
  1. * Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
  2. * Inclusion of a prior pregnancy in the main analysis population

Contacts and Locations

Study Contact

Study Director
CONTACT
1-877-283-6220
sunosipregnancyregistry@ppd.com

Study Locations (Sites)

Evidera, a PPD business unit
Morrisville, North Carolina, 27560
United States
PPD, Inc.
Wilmington, North Carolina, 28401
United States

Collaborators and Investigators

Sponsor: Axsome Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-31
Study Completion Date2029-09

Study Record Updates

Study Start Date2019-07-31
Study Completion Date2029-09

Terms related to this study

Keywords Provided by Researchers

  • Solriamfetol
  • SUNOSI
  • Axsome
  • Narcolepsy
  • Obstructive Sleep Apnea
  • Non-stimulant therapy
  • Dopamine norepinephrine reuptake inhibitor
  • Pregnancy outcomes
  • Infant outcomes

Additional Relevant MeSH Terms

  • Narcolepsy
  • Obstructive Sleep Apnea
  • Pregnant Women and Their Offspring