Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
- Registration Number
- NCT06525077
- Lead Sponsor
- Avadel
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo equivalent administered orally once nightly FT218 FT218 FT218 at stable dose (selected during earlier titration) administered orally once nightly
- Primary Outcome Measures
Name Time Method Epworth Sleepiness Scale (ESS) 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
- Secondary Outcome Measures
Name Time Method Patient Global Impression of change (PGI-C) End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period] Worsening of idiopathic hypersomnia symptoms as assessed by subject
Idiopathic Hypersomnia Severity Scale (IHSS) End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period] Change in total IHSS score
Clinical Global Impression of change (CGI-C) End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period] Worsening of idiopathic hypersomnia symptoms as assessed by clinician
Functional Outcomes of Sleep Questionnaire (FOSQ-10) End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period] Change in total FOSQ-10 score
Trial Locations
- Locations (7)
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Florida Pediatric Institute
🇺🇸Winter Park, Florida, United States
Clinical Research Institute
🇺🇸Stockbridge, Georgia, United States
Clinical Neurophysiology Services PC
🇺🇸Sterling Heights, Michigan, United States
Advanced Respiratory and Sleep Medicine
🇺🇸Huntersville, North Carolina, United States
Bogan Sleep Consultants
🇺🇸Columbia, South Carolina, United States
Tidewater Physicians Multispecialty Group (TPMG) Clinical Research
🇺🇸Williamsburg, Virginia, United States