Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
Completed · Phase 3 · NCT06525077
Conditions: Idiopathic Hypersomnia
At a glance
- Research payments reported, 2025
- $2.2M
- U.S. investigators named
- 16
- Sites paid
- 37
- Planned or actual enrollment
- 157
About the trial
- Sponsor
- Avadel
- Tested
- FT218 (drug), Placebo (other)
- Dates
- Started 2024-08-01; completion 2026-03-25
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-05-11. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Avadel Cns Pharmaceuticals, LLC reported $2.2M in research payments for this study in 2025 (37 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Robert C. Doekel JR., M.D. Sleep Medicine · Birmingham, AL
- William A. Nixon, MD Family Medicine · Guntersville, AL
- Daniel Norman, M.D. Sleep Medicine · Los Angeles, CA
- Andrew O. Schreiber, MD Neurosurgery · Santa Ana, CA
- Mohamed I. Ali Eltoum, M.D. Pulmonology · Saint Petersburg, FL
- Edward Mezerhane, MD Sleep Medicine · Miami, FL
- Phillip W. Nowlin, MD Family Medicine · Carrollton, GA
- Rahul B. Sangal, M.D. Sleep Medicine · Bloomfield Hills, MI
- Anup Banerjee, M.D. Pulmonology · Gastonia, NC
- Thomas P. Stern, M.D. Pulmonology · Huntersville, NC
- Bruce C. Corser, MD Pulmonology · Cincinnati, OH
- Ryan S. Drake, DO Neurology · Canton, OH
- Asim Roy, M.D. Sleep Medicine · Dublin, OH
- Richard K. Bogan, M.D. Pulmonology · Columbia, SC
- Adrian A. Santamaria, MD Neurology · Tomball, TX
- Richard A. Parisi, MD Sleep Medicine · Williamsburg, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Sleep Management Institute Intrepid Research $163,462
- Bogan Sleep Consultants LLC $156,453
- Global Research Holdings LLC $155,203
- Nw Houston Neurology and Comprehensive Sleep Medicine Center $127,177
- The Board of Trustees of the Leland Stanford Junior University DBA Stanford University $120,011
- Advanced Respiratory and Sleep Medicine $119,238
- Sleep and Attention Disorders Institute $102,564
- University of Kansas Medical Center Research Institute Inc DBA Kumc Research Institute $97,699
- Tpmg Clinical Research Williamsburg $97,616
- Clayton Sleep Institute LLC $78,718
- University Hospitals Cleveland Medical Center $72,477
- Sleep Practitioners LLC $63,312
- Pharmadev Clinical Research Institute LLC $60,341
- Lakeview Clinical Research LLC $53,859
- Clinical Research of Gastonia $52,401
- Abington Neurological Associates LTD $52,124
- Metrohealth System, OH $48,473
- Sleepcare Research Institute Inc DBA Clinical Research Institute $47,606
- Dent Neurosciences Research Center Inc $45,310
- Geisinger Clinic $44,770
- State of West Virginia DBA West Virginia University $41,505
- The Medical University of South Carolina $40,340
- Pasadena Center for Medical Research (pcmr) $36,379
- Sds Clinical Trials $32,224
- Indiana University Health, IN $31,193
- St Lukes Hospital, MO $29,773
- Memorial Pulmonary and Sleep Disorders PA DBA the Respire Institute $29,224
- Ohio Sleep Medicine Institute $26,117
- Neurocare Center Inc $26,041
- Southeastern Research Center $25,000
- Velocity Clinical Research Inc $21,500
- Cleveland Clinic, OH $21,206
- The Cardiovascular Group DBA Virginia Hearth $15,783
- Phoenix Medical Group PC $13,500
- Santa Monica Clinical Trials $10,700
- Comprehensive Sleep Medicine Associates PA $8,000
- Sleep Disorders Center of Alabama $1,932
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.