Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

PHASE3RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

September 30, 2026

Conditions
Idiopathic Hypersomnia
Interventions
DRUG

FT218

Sodium oxybate for extended-release oral suspension

OTHER

Placebo

Matched placebo equivalent for oral suspension

Trial Locations (7)

23188

RECRUITING

Tidewater Physicians Multispecialty Group (TPMG) Clinical Research, Williamsburg

28078

RECRUITING

Advanced Respiratory and Sleep Medicine, Huntersville

29201

RECRUITING

Bogan Sleep Consultants, Columbia

30281

RECRUITING

Clinical Research Institute, Stockbridge

32789

RECRUITING

Florida Pediatric Institute, Winter Park

48314

RECRUITING

Clinical Neurophysiology Services PC, Sterling Heights

80301

RECRUITING

Alpine Clinical Research Center, Boulder

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Avadel

INDUSTRY

NCT06525077 - Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) | Biotech Hunter | Biotech Hunter