Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

Description

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

Idiopathic Hypersomnia

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Study Overview

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Study Details

Study overview

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.

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH)

Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

Condition
Idiopathic Hypersomnia
Intervention / Treatment

-

Contacts and Locations

Boulder

Alpine Clinical Research Center, Boulder, Colorado, United States, 80301

Winter Park

Florida Pediatric Institute, Winter Park, Florida, United States, 32789

Stockbridge

Clinical Research Institute, Stockbridge, Georgia, United States, 30281

Sterling Heights

Clinical Neurophysiology Services PC, Sterling Heights, Michigan, United States, 48314

Huntersville

Advanced Respiratory and Sleep Medicine, Huntersville, North Carolina, United States, 28078

Columbia

Bogan Sleep Consultants, Columbia, South Carolina, United States, 29201

Williamsburg

Tidewater Physicians Multispecialty Group (TPMG) Clinical Research, Williamsburg, Virginia, United States, 23188

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Primary diagnosis of idiopathic hypersomnia
  • * Total ESS score at Screening \> 11 if not on prior oxybate
  • * Average nightly total sleep time of \> 7 hours
  • * May use stimulants/alerting agents but dose and regimen must have been stable for 2 months prior to Screening, and remain stable until the double-blind, randomized withdrawal visit
  • * Females of childbearing potential must use highly effective contraception for 2 months prior to Baseline, throughout the study, and for 30 days after the last dose of study drug
  • * Males with female partners of childbearing potential must use condoms throughout the study and for 30 days after the last dose of study drug
  • * Willing and able to provide informed consent and comply with the requirements of the study
  • * Pregnant, nursing or lactating females
  • * Hypersomnia due to another medical, behavioral, sleep, or psychiatric condition
  • * Untreated or incompletely treated sleep apnea in patients with an apnea-hypopnea index (AHI) ≥ 15 by American Academy of Sleep Medicine (AASM) 1A criteria
  • * Clinically significant parasomnias
  • * History or presence of seizures, head trauma, succinic semialdehyde dehydrogenase deficiency, uncontrolled hypothyroidism, and/or significant hepatic impairment
  • * History or presence of bipolar and related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders
  • * Ongoing or past (within 1 year) major depressive episode
  • * At risk for suicide or history of suicide attempt
  • * If not on oxybate at Screening, treatment or planned treatment with any central nervous system (CNS) sedating agents during study
  • * Current or past substance use disorder (including alcohol or cannabinoids)
  • * Excessive caffeine consumption (\> 600 mg/day)
  • * Prior treatment with either FT218 or LUMRYZ

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Avadel,

Study Record Dates

2026-09