NarcolepsyNCT06413420
SUNOSI® (Solriamfetol) Pregnancy Registry
An observational study of Narcolepsy and Obstructive Sleep Apnea, run by Axsome Therapeutics, Inc. at 2 sites in United States.
Trial summary
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- What is being tested?
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants and No treatment
- How many people
- 1,731 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2019to Sep 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include pregnant women of any age who reside in the US and Canada, 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.
Who may be able to join
- 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
- Provides written informed consent to participate in the study
- Authorization for her HCP(s) to provide data to the registry
Who cannot join
- Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Evidera, a PPD business unit
Morrisville, North Carolina, 27560
- Recruiting
PPD, Inc.
Wilmington, North Carolina, 28401
About this study
Official title: SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).
Read the detailed description
The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and risks of exposure during pregnancy and make informed treatment decisions.
The study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected.
- Being tested
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Keywords
- Solriamfetol, SUNOSI, Axsome, Narcolepsy, Obstructive Sleep Apnea, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Pregnancy outcomes, Infant outcomes
- Medical subject headings
- Narcolepsy, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunosi (solriamfetol)Drug
Exposure to at least 1 dose of solriamfetol at any time during pregnancy or in the relevant exposure window before conception.
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 or in the relevant exposure window before conception.
No treatmentOther
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA | Pregnant women with a diagnosis of narcolepsy or OSA Receives: Drug: Sunosi (solriamfetol) | |
| Cohort 2: Unexposed participants with narcolepsy or OSA | Pregnant women with a diagnosis of narcolepsy or OSA Receives: Other: No treatment | |
| Cohort 3: Other-exposed participants with narcolepsy or OSA | Pregnant women with a diagnosis of narcolepsy or OSA Receives: 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 Receives: Drug: Sunosi (solriamfetol) | |
| Cohort 5: Other-exposed participants without narcolepsy or OSA | Pregnant women without a diagnosis of narcolepsy or OSA Receives: Drug: Other prescription wake-promoting medications or stimulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Safety
Measured: Baseline up to 12 months after pregnancy outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start31 Jul 2019
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,731 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413420
- Sponsor's protocol ID
- JZP110-402
- Status last verified
- Sep 2026
- First submitted
- 9 May 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No