Evaluating FT218 for treating Idiopathic Hypersomnia
A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH)
This study is testing a new nighttime medication called FT218 to see if it helps people with idiopathic hypersomnia feel more awake and alert.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Avadel Industry-sponsored |
| Locations | 7 sites (Boulder, Colorado and 6 other locations) |
| Trial ID | NCT06525077 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a double-blind, placebo-controlled, randomized withdrawal study assessing the safety and efficacy of FT218, a once-nightly formulation of sodium oxybate, in patients diagnosed with idiopathic hypersomnia. Participants will be enrolled regardless of their current treatment with oxybate therapy or stimulants. The study aims to determine the effectiveness of FT218 over an estimated duration of 18 weeks, including a screening period. The trial will take place across multiple centers to gather diverse data on the drug's performance.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with idiopathic hypersomnia who meet specific eligibility criteria regarding sleep patterns and current treatments.
Not a fit: Patients with hypersomnia due to other medical, behavioral, sleep, or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from idiopathic hypersomnia by providing a more effective management option.
How similar studies have performed: Previous studies on sodium oxybate have shown promising results in treating sleep disorders, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 this trial is running
Boulder, Colorado and 6 other locations
- Alpine Clinical Research Center — Boulder, Colorado, United States (Recruiting)
- Florida Pediatric Institute — Winter Park, Florida, United States (Recruiting)
- Clinical Research Institute — Stockbridge, Georgia, United States (Recruiting)
- Clinical Neurophysiology Services PC — Sterling Heights, Michigan, United States (Recruiting)
- Advanced Respiratory and Sleep Medicine — Huntersville, North Carolina, United States (Recruiting)
- Bogan Sleep Consultants — Columbia, South Carolina, United States (Recruiting)
- Tidewater Physicians Multispecialty Group (TPMG) Clinical Research — Williamsburg, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Gretchen Richards, MS
- Email: grichards@avadel.com
- Phone: (636) 449-1830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.