CompletedPhase 3

Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

United States157 participantsStarted 2024-08-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 hist…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Epworth Sleepiness Scale (ESS)

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

Trial details

NCT IDNCT06525077

SponsorAvadel

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-25

View on ClinicalTrials.gov More Idiopathic Hypersomnia trials