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Sodium Oxybate

FT218 for Idiopathic Hypersomnia

Phase 3
Recruiting
Research Sponsored by Avadel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Total ESS score at Screening and Baseline > 11 if not on prior oxybate
Primary diagnosis of idiopathic hypersomnia
Must not have
Clinically significant parasomnias
Hypersomnia due to another medical, behavioral, sleep, or psychiatric condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of stable dose visit to end of double-blind, randomized withdrawal visit [week 12 to week 14; 2 week period]
Awards & highlights

Summary

"This trial will test the effectiveness and safety of a new drug called FT218 for people with idiopathic hypersomnia. It is a long-term study that will last about 42 weeks and includes an open

Who is the study for?
This trial is for individuals with idiopathic hypersomnia, which causes excessive daytime sleepiness. Participants can join whether or not they're currently using oxybate therapy or stimulants. Key exclusions aren't specified but typically would include those with other health conditions that could interfere with the study.
What is being tested?
The trial is testing FT218, a once-nightly extended-release oral suspension of sodium oxybate, against a placebo to see if it's safe and effective for treating idiopathic hypersomnia. It's designed as a double-blind study where neither participants nor researchers know who gets the real drug versus placebo.
What are the potential side effects?
While specific side effects are not listed here, sodium oxybate can commonly cause dizziness, nausea, headache, vomiting, sleep disturbances and less often may lead to more serious issues like breathing problems or mental health changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My sleepiness score is over 11 and I haven't taken oxybate before.
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I have been diagnosed with idiopathic hypersomnia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe sleep disorders that affect my behavior.
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I have excessive sleepiness not caused by another health issue.
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I have not had seizures, serious head injuries, specific genetic disorders, uncontrolled thyroid issues, or severe liver problems.
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I have sleep apnea with an AHI of 15 or more that's not fully treated.
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I have had a major depressive episode in the past year.
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I am taking or will take medication that makes me sleepy.
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I have previously been treated with FT218 or LUMRYZ.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of stable dose visit to end of double-blind, randomized withdrawal visit [week 12 to week 14; 2 week period]
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of stable dose visit to end of double-blind, randomized withdrawal visit [week 12 to week 14; 2 week period] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Epworth Sleepiness Scale (ESS)
Secondary outcome measures
Clinical Global Impression of change (CGI-C)
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Idiopathic Hypersomnia Severity Scale (IHSS)
+1 more

Side effects data

From 2020 Phase 3 trial • 212 Patients • NCT02720744
9%
Enuresis
5%
Dizziness
5%
Vomiting
4%
Weight Decreased
4%
Headache
4%
Nausea
4%
Somnolence
3%
Decreased Appetite
3%
Nasopharyngitis
1%
Suicidal ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
FT218 9g Group
Placebo 9g Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FT218Experimental Treatment1 Intervention
FT218 at stable dose (selected during earlier titration) administered orally once nightly
Group II: PlaceboPlacebo Group1 Intervention
Placebo equivalent administered orally once nightly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FT218
2020
Completed Phase 3
~400

Find a Location

Who is running the clinical trial?

AvadelLead Sponsor
2 Previous Clinical Trials
396 Total Patients Enrolled
~100 spots leftby Feb 2026
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