FT218 for Idiopathic Hypersomnia

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Avadel

Must not be taking: CNS sedating agents

Disqualifiers: Pregnancy, Sleep apnea, Seizures, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you can continue using stimulants or alerting agents if your dose and regimen have been stable for 2 months before the study and remain stable during the trial.

What data supports the effectiveness of the drug FT218 for idiopathic hypersomnia?

Research shows that a similar drug, lower-sodium oxybate, is effective in treating idiopathic hypersomnia, as well as excessive daytime sleepiness in narcolepsy. This suggests that FT218, which is a form of sodium oxybate, may also be effective for idiopathic hypersomnia. ^{1 2 3 4 5}

Is FT218 safe for humans?

FT218, a form of sodium oxybate, has been studied for safety in both healthy adults and those with idiopathic hypersomnia and narcolepsy. It is generally considered safe, with a lower sodium version being approved by the FDA for its reduced risk of high sodium intake, which is important for people with heart-related conditions. ^{1 2 6 7 8}

How is the drug FT218 different from other treatments for idiopathic hypersomnia?

FT218 is unique because it is a once-nightly formulation of sodium oxybate, unlike current treatments that require taking two doses each night. This makes it more convenient for patients, as they only need to take it once before bed. ^{1 3 5 6 9}

Eligibility Criteria

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.

Inclusion Criteria

Willing and able to provide informed consent and comply with the requirements of the study

I am using or will use effective birth control before, during, and for 30 days after the study.

I have been on the same dose of medication for alertness for 2 months.

Exclusion Criteria

Pregnant, nursing or lactating females

I have excessive sleepiness not caused by another health issue.

I have not had seizures, serious head injuries, specific genetic disorders, uncontrolled thyroid issues, or severe liver problems.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FT218 or placebo once nightly during the double-blind, randomized withdrawal phase

12 weeks

Randomized Withdrawal

Participants continue with FT218 or switch to placebo to assess withdrawal effects

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FT218 (Sodium Oxybate)

Trial Overview 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.

Participant Groups

Group I: FT218 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Placebo equivalent administered orally once nightly

FT218 is already approved in United States for the following indications:

🇺🇸 Approved in United States as LUMRYZ for:

• Excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy
• Idiopathic hypersomnia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Florida Pediatric Institute Winter Park, FL

Clinical Research Institute Stockbridge, GA

Clinical Neurophysiology Services PC Sterling Heights, MI

Alpine Clinical Research Center Boulder, CO

More Trial Locations

Who Is Running the Clinical Trial?

Avadel Lead Sponsor

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia. [2022] Label="Purpose" NlmCategory="UNASSIGNED">To report the efficacy and safety of lower-sodium oxybate (LXB; Xywav®) during the open-label titration and optimization period (OLT) and stable-dose period (SDP) in a clinical study for the treatment of idiopathic hypersomnia.

2. United States pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of low-sodium oxybate in an open-label extension period of a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia. [2023] To evaluate 6-month efficacy and safety of low-sodium oxybate in people with idiopathic hypersomnia during an open-label extension period (OLE) of a phase 3 clinical trial.

3. New Zealand pubmed.ncbi.nlm.nih.gov

Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution: A Lower-Sodium Alternative for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy. [2022] Lower-sodium oxybate (LXB) is an oxybate medication approved to treat cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy 7 years of age and older in the United States. LXB was developed as an alternative to sodium oxybate (SXB), because the incidence of cardiovascular comorbidities is higher in patients with narcolepsy and there is an elevated cardiovascular risk associated with high sodium consumption. LXB has a unique formulation of calcium, magnesium, potassium, and sodium ions, containing 92% less sodium than SXB. Whereas the active oxybate moiety is the same for LXB and SXB, their pharmacokinetic profiles are not bioequivalent; therefore, a phase 3 trial in participants with narcolepsy was conducted for LXB. This review summarizes the background on oxybate as a therapeutic agent and its potential mechanism of action on the gamma-aminobutyric acid type B (GABAB) receptor at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons. The rationale leading to the development of LXB as a lower-sodium alternative to SXB and the key efficacy and safety data supporting its approval for both adult and pediatric patients with narcolepsy are also discussed. LXB was approved in August 2021 in the United States for the treatment of idiopathic hypersomnia in adults. Potential future developments in the field of oxybate medications may include novel formulations and expanded indications for other diseases.

4. United States pubmed.ncbi.nlm.nih.gov

A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. [2015] To evaluate the long-term safety and efficacy of nightly sodium oxybate for the treatment of narcolepsy.

5. United States pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled study demonstrates sodium oxybate is effective for the treatment of excessive daytime sleepiness in narcolepsy. [2015] Assess the efficacy of sodium oxybate for the treatment of narcolepsy with an emphasis on excessive daytime sleepiness.

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults. [2021] FT218 is an investigational, once-nightly, modified-release formulation of sodium oxybate (SO). SO effectively treats excessive daytime sleepiness and cataplexy in patients with narcolepsy. Current approved SO formulations, at effective doses of 6, 7.5, and 9 g, require twice-nightly divided dosing, with the first dose taken at bedtime and the second 2.5-4 h later. The purpose of the following studies was to evaluate the pharmacokinetic properties, safety profile, and tolerability of FT218 in healthy adults.

7. England pubmed.ncbi.nlm.nih.gov

Calcium, magnesium, potassium, and sodium oxybates oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy. [2023] Lower-sodium oxybate (LXB) is a novel formulation that is approved by the US Food and Drug Administration (FDA) to treat cataplexy and excessive daytime sleepiness (EDS) in adult patients and children ≥7 years with narcolepsy. LXB contains 92% less sodium than sodium oxybate (SXB), which adds 550-1640 mg of sodium/day at usual doses of 3-9 g/day. The FDA has declared LXB to be clinically superior to SXB due to greater safety by reducing the chronic sodium load. Narcolepsy patients have high comorbidities for hypertension and cardiovascular disease conditions, which can be adversely affected by high sodium intake.

8. Germany pubmed.ncbi.nlm.nih.gov

A 2-week, polysomnographic, safety study of sodium oxybate in obstructive sleep apnea syndrome. [2021] Sodium oxybate (SXB) is approved for cataplexy and excessive daytime sleepiness in narcolepsy. Obstructive sleep apnea syndrome (OSAS) affects ∼9-50% of narcoleptics. Effects of 2-week SXB administration on apnea-hypopnea index (AHI), oxygen saturation (SaO(2)), and sleep architecture were investigated in OSAS patients.

9. England pubmed.ncbi.nlm.nih.gov

Development of a lower-sodium oxybate formulation for the treatment of patients with narcolepsy and idiopathic hypersomnia. [2022] Sodium oxybate (SXB) is a standard of care for cataplexy, excessive daytime sleepiness, and disrupted nighttime sleep in narcolepsy. At recommended dosages in adults (6-9 g/night), SXB increases daily dietary intake of sodium by 1100-1640 mg. Because excess sodium intake is associated with increased blood pressure and cardiovascular risk, an oxybate formulation containing 92% less sodium than SXB (lower-sodium oxybate; LXB) was developed to provide an alternative oxybate treatment option. In 2020, LXB was approved for treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy, and in 2021, for treatment of idiopathic hypersomnia in adults.