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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 baseline up to 12 months after pregnancy outcome
Awards & highlights

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
  • Pregnancy
  • Obstructive Sleep Apnea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 12 months after pregnancy outcome
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 12 months after pregnancy outcome for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long-term Safety

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
30 Previous Clinical Trials
8,676 Total Patients Enrolled
4 Trials studying Narcolepsy
207 Patients Enrolled for Narcolepsy
~844 spots leftby Sep 2029
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