Status:
RECRUITING
Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
Lead Sponsor:
Avadel
Conditions:
Idiopathic Hypersomnia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 extende...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06525077
Start Date
August 1 2024
End Date
September 1 2026
Last Update
March 20 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Alpine Clinical Research Center
Boulder, Colorado, United States, 80301
2
Florida Pediatric Institute
Winter Park, Florida, United States, 32789
3
Clinical Research Institute
Stockbridge, Georgia, United States, 30281
4
Clinical Neurophysiology Services PC
Sterling Heights, Michigan, United States, 48314