Evaluating FT218 for treating Idiopathic Hypersomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Gretchen Richards, MS
• Email: grichards@avadel.com
• Phone: (636) 449-1830

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term test of TAK-360 in people with narcolepsy or idiopathic hypersomnia

  This study tests TAK-360 over an extended period to see if it is tolerable for people with narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia who completed an earlier TAK-360 trial.

  Recruiting at 33 sites Phase 2/3 Takeda · Chula Vista, California and 32 other locations · NCT07646678

• Expanded-dosing Xywav vs placebo in narcolepsy and IH

  This study tests whether expanded nightly dosing of Xywav helps adults with narcolepsy or idiopathic hypersomnia, compared with placebo.

  Recruiting at 15 sites Phase 3 Jazz Pharmaceuticals · Birmingham, Alabama and 14 other locations · NCT07625280

• Phase 3 HBS-301 for idiopathic hypersomnia

  This trial will test whether the oral medicine HBS-301 helps adults with idiopathic hypersomnia reduce daytime sleepiness, sleep inertia, and fatigue.

  Recruiting at 42 sites Phase 3 Harmony Biosciences Management, Inc. · Birmingham, Alabama and 41 other locations · NCT07500090

• Long-term ORX750 treatment for people with narcolepsy or idiopathic hypersomnia

  This open-label extension will try continued ORX750 treatment in people with narcolepsy or idiopathic hypersomnia who completed the earlier ORX750 parent study.

  Recruiting at 24 sites Phase 2 Centessa Pharmaceuticals (UK) Limited · Auburn, Alabama and 23 other locations · NCT07096674

• Diet changes to reduce sleepiness in narcolepsy and idiopathic hypersomnia

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  Recruiting University of Sydney · Macquarie Park, New South Wales · NCT07006233

• Evaluating TAK-360 for daytime sleepiness in adults with Idiopathic Hypersomnia

  This study is testing a new medication called TAK-360 to see if it can help adults with Idiopathic Hypersomnia feel less sleepy during the day.

  Recruiting at 28 sites Phase 2 Takeda · Redwood City, California and 28 other locations · NCT06812078

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.