NCT06413420

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,731

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jul 2019Sep 2029

Study Start

First participant enrolled

July 31, 2019

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

10.1 years

First QC Date

May 9, 2024

Last Update Submit

May 9, 2024

Conditions

NarcolepsyObstructive Sleep ApneaPregnant Women and Their Offspring

Keywords

SolriamfetolSUNOSIAxsomeNarcolepsyObstructive Sleep ApneaNon-stimulant therapyDopamine norepinephrine reuptake inhibitorPregnancy outcomesInfant outcomes

Outcome Measures

Primary Outcomes (1)

  • Long-term Safety

    Baseline up to 12 months after pregnancy outcome

Study Arms (5)

Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA

Pregnant women with a diagnosis of narcolepsy or OSA

Drug: Sunosi (solriamfetol)

Cohort 2: Unexposed participants with narcolepsy or OSA

Pregnant women with a diagnosis of narcolepsy or OSA

Other: No treatment

Cohort 3: Other-exposed participants with narcolepsy or OSA

Pregnant women with a diagnosis of narcolepsy or OSA

Drug: Other prescription wake-promoting medications or stimulants

Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA

Pregnant women without a diagnosis of narcolepsy or OSA

Drug: Sunosi (solriamfetol)

Cohort 5: Other-exposed participants without narcolepsy or OSA

Pregnant women without a diagnosis of narcolepsy or OSA

Drug: Other prescription wake-promoting medications or stimulants

Interventions

Sunosi (solriamfetol)DRUG

Exposure to at least 1 dose of solriamfetol at any time during pregnancy.

Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSACohort 4: Solriamfetol-exposed participants without narcolepsy or OSA
Other prescription wake-promoting medications or stimulantsDRUG

Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.

Cohort 3: Other-exposed participants with narcolepsy or OSACohort 5: Other-exposed participants without narcolepsy or OSA
No treatmentOTHER

No treatment

Cohort 2: Unexposed participants with narcolepsy or OSA

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include pregnant women of any age who reside in a country where solriamfetol is available for the treatment of narcolepsy or OSA, provide consent to participate as well as medical releases for their healthcare providers (HCPs) to provide data to the registry, and meet the criteria for inclusion into 1 of the 5 cohorts.

You may qualify if:

  • 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
  • Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA
  • Provides written informed consent to participate in the study
  • Authorization for her HCP(s) to provide data to the registry

You may not qualify if:

  • Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Evidera, a PPD business unit

Morrisville, North Carolina, 27560, United States

RECRUITING

PPD, Inc.

Wilmington, North Carolina, 28401, United States

RECRUITING

Related Links

MeSH Terms

Conditions

NarcolepsySleep Apnea, Obstructive

Interventions

solriamfetolCentral Nervous System Stimulants

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Central Study Contacts

Study Director

CONTACT

1-877-283-6220sunosipregnancyregistry@ppd.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 14, 2024

Study Start

July 31, 2019

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)