SUNOSI® (Solriamfetol) Pregnancy Registry

Part of paid clinical trials in Morrisville, North Carolina.

Sponsor
Axsome Therapeutics, Inc.
Study ID
NCT06413420
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sunosi (solriamfetol) — DRUG
    Exposure to at least 1 dose of solriamfetol at any time during pregnancy.
  • Other prescription wake-promoting medications or stimulants — DRUG
    Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.
  • No treatment — OTHER
    No treatment

Study Details

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).

Key Dates

Start date
Jul 31, 2019
Status verified
May 2024
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
1,731 participants (estimated)

Arms

  • Arm: Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA
    Pregnant women with a diagnosis of narcolepsy or OSA
  • Arm: Cohort 2: Unexposed participants with narcolepsy or OSA
    Pregnant women with a diagnosis of narcolepsy or OSA
  • Arm: Cohort 3: Other-exposed participants with narcolepsy or OSA
    Pregnant women with a diagnosis of narcolepsy or OSA
  • Arm: Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA
    Pregnant women without a diagnosis of narcolepsy or OSA
  • Arm: Cohort 5: Other-exposed participants without narcolepsy or OSA
    Pregnant women without a diagnosis of narcolepsy or OSA

Primary Outcome Measure

Long-term Safety [ Time Frame: Baseline up to 12 months after pregnancy outcome ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Evidera, a PPD business unitMorrisvilleNorth Carolina27560-
PPD, Inc.WilmingtonNorth Carolina28401-

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Evidera, a PPD business unit· Morrisville, NCPPD, Inc.· Wilmington, NC

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