Idiopathic HypersomniaPhase 3NCT06525077
Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
A Phase 3 study testing FT218 in people with Idiopathic Hypersomnia, run by Avadel at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Hypersomnia
- What is being tested?
- FT218
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Aug 2024to 25 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Alpine Clinical Research Center
Boulder, Colorado, 80301
Bogan Sleep Consultants
Columbia, South Carolina, 29201
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, 28078
Clinical Neurophysiology Services PC
Sterling Heights, Michigan, 48314
Clinical Research Institute
Stockbridge, Georgia, 30281
Tidewater Physicians Multispecialty Group (TPMG) Clinical Research
Williamsburg, Virginia, 23188
Florida Pediatric Institute
Winter Park, Florida, 32789
About this study
Official title: 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.
- Conditions
- Idiopathic Hypersomnia
- Being tested
- FT218, Placebo
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT218Drug
Also called LUMRYZ
Sodium oxybate for extended-release oral suspension
PlaceboOther
Matched placebo equivalent for oral suspension
| Study group | Role | What they receive |
|---|---|---|
| FT218 | Experimental | FT218 at stable dose (selected during earlier titration) administered orally once nightly Receives: Drug: FT218 |
| Placebo | Placebo comparator | Placebo equivalent administered orally once nightly Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth Sleepiness Scale (ESS)
Change in total ESS score
Measured: 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)
Worsening of idiopathic hypersomnia symptoms as assessed by subject
Measured: 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
Measured: 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
Measured: 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
Measured: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Aug 2024
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic HypersomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avadel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525077
- Sponsor's protocol ID
- CLFT218-2401
- Status last verified
- May 2026
- First submitted
- 18 Jul 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH)
- ClinicalTrials.gov ID
- NCT06525077
- Acronym / sponsor ID
- CLFT218-2401
- Conditions
- Idiopathic Hypersomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- AvadelIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FT218 | Experimental | Drug: FT218FT218 at stable dose (selected during earlier titration) administered orally once nightly |
| Placebo | Placebo comparator | Other: PlaceboPlacebo equivalent administered orally once nightly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT218Also: LUMRYZSodium oxybate for extended-release oral suspension | Drug | FT218 |
| PlaceboMatched placebo equivalent for oral suspension | Other | Placebo |
Primary outcome
Epworth Sleepiness Scale (ESS)
Time frame: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Change in total ESS score
4 secondary outcomes
Patient Global Impression of change (PGI-C)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Hypersomnia
RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2/3
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1, Narcolepsy Type 2
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
Narcolepsy, Idiopathic Hypersomnia
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
Idiopathic Hypersomnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FT218 in people with Idiopathic Hypersomnia, run by Avadel at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epworth Sleepiness Scale (ESS) (time frame: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.