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Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

NCT06525077 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2026-05-11

No results posted yet for this study

Summary

This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218. FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension. The study will enroll subjects who are diagnosed with idiopathic hypersomnia. Subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulants/alerting agents at study entry. The estimated total duration of study for each subject is approximately 18 weeks, including the Screening period.

Conditions

Interventions

DRUG

FT218

Sodium oxybate for extended-release oral suspension

OTHER

Placebo

Matched placebo equivalent for oral suspension

Sponsors & Collaborators

  • Avadel

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-03-25
Completion
2026-03-25
FDA Drug
Yes

Countries

  • United States

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 NCT06525077 on ClinicalTrials.gov