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Cohort 3: Other-exposed participants with narcolepsy or OSA for Narcolepsy
N/A
Recruiting
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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).
Eligible Conditions
- Narcolepsy
- Obstructive Sleep Apnea
- Pregnancy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 5: Other-exposed participants without narcolepsy or OSAExperimental Treatment1 Intervention
Pregnant women without a diagnosis of narcolepsy or OSA
Group II: Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSAExperimental Treatment1 Intervention
Pregnant women without a diagnosis of narcolepsy or OSA
Group III: Cohort 3: Other-exposed participants with narcolepsy or OSAExperimental Treatment1 Intervention
Pregnant women with a diagnosis of narcolepsy or OSA
Group IV: Cohort 2: Unexposed participants with narcolepsy or OSAExperimental Treatment1 Intervention
Pregnant women with a diagnosis of narcolepsy or OSA
Group V: Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSAExperimental Treatment1 Intervention
Pregnant women with a diagnosis of narcolepsy or OSA
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Who is running the clinical trial?
Axsome Therapeutics, Inc.Lead Sponsor
31 Previous Clinical Trials
9,196 Total Patients Enrolled
4 Trials studying Narcolepsy
207 Patients Enrolled for Narcolepsy
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