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Clinical trial

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

ID
Name
JZP110-402
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).
Trial arms
Trial start
2019-07-31
Estimated PCD
2029-09-01
Trial end
2029-09-01
Status
Recruiting
Treatment
Sunosi (solriamfetol)
Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
Arms:
Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA, Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA
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.
Arms:
Cohort 3: Other-exposed participants with narcolepsy or OSA, Cohort 5: Other-exposed participants without narcolepsy or OSA
No treatment
No treatment
Arms:
Cohort 2: Unexposed participants with narcolepsy or OSA
Size
1731
Primary endpoint
Long-term Safety
Baseline up to 12 months after pregnancy outcome
Eligibility criteria
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) * Inclusion of a prior pregnancy in the main analysis population
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1731, 'type': 'ESTIMATED'}}
Updated at
2024-05-14

1 organization

2 products

3 indications

Indication
Pregnancy
Product
Wake-promoting medications
Organization
Axsome Therapeutics
Indication
Narcolepsy
Indication
Obstructive Sleep Apnea
Product
Sunosi