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An Open Label Study of FT218 in Subjects With Narcolepsy

NCT04451668 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-10-02

No results posted yet for this study

Summary

An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

Conditions

  • Narcolepsy
  • Cataplexy
  • Excessive Daytime Somnolence
  • Sleep Disorder
  • Sleep Disturbance
  • Sleep Wake Disorders

Interventions

DRUG

FT218

once nightly sodium oxybate extended release

Sponsors & Collaborators

  • Avadel

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2023-12-22
Completion
2024-11-18
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04451668 on ClinicalTrials.gov