Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

NCT06525077 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: CLFT218-2401
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief 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

Idiopathic Hypersomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient Global Impression of change (PGI-C)

  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)

  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)

  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)

  End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]

Study Arms (2)

FT218

EXPERIMENTAL

FT218 at stable dose (selected during earlier titration) administered orally once nightly

Drug: FT218

Placebo

PLACEBO COMPARATOR

Placebo equivalent administered orally once nightly

Other: Placebo

Interventions

FT218 DRUG

Sodium oxybate for extended-release oral suspension

Also known as: LUMRYZ

FT218

Placebo OTHER

Matched placebo equivalent for oral suspension

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avadel: lead

Study Sites (7)

Alpine Clinical Research Center

Boulder, Colorado, 80301, United States

Location

Florida Pediatric Institute

Winter Park, Florida, 32789, United States

Location

Clinical Research Institute

Stockbridge, Georgia, 30281, United States

Location

Clinical Neurophysiology Services PC

Sterling Heights, Michigan, 48314, United States

Location

Advanced Respiratory and Sleep Medicine

Huntersville, North Carolina, 28078, United States

Location

Bogan Sleep Consultants

Columbia, South Carolina, 29201, United States

Location

Tidewater Physicians Multispecialty Group (TPMG) Clinical Research

Williamsburg, Virginia, 23188, United States

Location

Related Links

• REVITALYZ Study Website

MeSH Terms

Conditions

Idiopathic Hypersomnia

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For the double-blind, randomized withdrawal portion of the study, the subject and all members of the study team will remain blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)