Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
Completed · Phase 3 · Has a placebo group
Conditions studied: Idiopathic Hypersomnia
In brief
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.
Key facts
- Study ID
- NCT06525077
- Run by
- Avadel
- People needed
- 157
- Starts
- 2024-08-01
- Expected to finish
- 2026-03-25
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Alpine Clinical Research Center — Boulder, Colorado, United States
- Florida Pediatric Institute — Winter Park, Florida, United States
- Clinical Research Institute — Stockbridge, Georgia, United States
- Clinical Neurophysiology Services PC — Sterling Heights, Michigan, United States
- Advanced Respiratory and Sleep Medicine — Huntersville, North Carolina, United States
- Bogan Sleep Consultants — Columbia, South Carolina, United States
- Tidewater Physicians Multispecialty Group (TPMG) Clinical Research — Williamsburg, Virginia, United States
Full record on ClinicalTrials.gov
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