NCT06413420 · Axsome Therapeutics, Inc.
SUNOSI® (Solriamfetol) Pregnancy Registry
What this study is about
The SUNOSI (solriamfetol) Pregnancy Registry is a forward-looking, 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).
View original scientific 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).
Interventions
DRUG
Sunosi (solriamfetol)
Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
DRUG
Other prescription wake-promoting medications or stimulants
Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.
OTHER
No treatment
No treatment
Primary outcome measures
Long-term Safety
Time frame: Baseline up to 12 months after pregnancy outcome
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
Where
- Morrisville, North Carolina
- Wilmington, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2024 · Source of record for eligibility and locations