Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Hypersomnia
• Intervention / Treatment: Drug: FT218; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center
  • Florida
    • Winter Park, Florida, United States, 32789
      • Florida Pediatric Institute
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Institute
  • Michigan
    • Sterling Heights, Michigan, United States, 48314
      • Clinical Neurophysiology Services PC
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Advanced Respiratory and Sleep Medicine
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants
  • Virginia
    • Williamsburg, Virginia, United States, 23188
      • Tidewater Physicians Multispecialty Group (TPMG) Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FT218; FT218 at stable dose (selected during earlier titration) administered orally once nightly	Drug: FT218; Sodium oxybate for extended-release oral suspension; Other Names: LUMRYZ
Placebo Comparator: Placebo; Placebo equivalent administered orally once nightly	Other: Placebo; Matched placebo equivalent for oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Scale (ESS)	Change in total ESS score	End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of change (PGI-C)	Worsening of idiopathic hypersomnia symptoms as assessed by subject	End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Idiopathic Hypersomnia Severity Scale (IHSS)	Change in total IHSS score	End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Clinical Global Impression of change (CGI-C)	Worsening of idiopathic hypersomnia symptoms as assessed by clinician	End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Functional Outcomes of Sleep Questionnaire (FOSQ-10)	Change in total FOSQ-10 score	End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]

Collaborators and Investigators

• Sponsor: Avadel

Publications and helpful links

Helpful Links

• REVITALYZ Study Website

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): March 25, 2026
• Study Completion (Actual): March 25, 2026

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Disorders of Excessive Somnolence; Idiopathic Hypersomnia
• Other Study ID Numbers: CLFT218-2401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No