An Open Label Study of FT218 in Subjects With Narcolepsy — RESTORE  

Sleep Disturbance Clinical Trial

Official title: Open Label Study of Safety/Tolerability of Once Nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy Patients That Have and Have Not Been Previously Maintained on Twice-nightly Sodium Oxybate IR

Status Completed

Clinical Trial Summary

An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

Clinical Trial Description

This study will enroll subjects with narcolepsy, either NT1 or NT2, who completed the FT218 Phase 3 REST-ON study or eligible subjects with narcolepsy currently receiving a stable dose of twice nightly sodium oxybate IR or mixed salts oxybate (regardless of whether they participated in the REST-ON study), or subjects who are naïve to oxybate therapy (i.e., FT218, twice nightly sodium oxybate IR or mixed salts oxybate). Following a screening period, subjects who meet the entry criteria will be enrolled into the study. Subjects who completed the FT218 Phase 3 REST-ON study will initiate treatment with FT218 at 4.5 g and will follow a titration schedule up to the highest tolerate dose (up to 9 g), or the dose deemed effective by the investigator. Subjects previously maintained on twice nightly sodium oxybate IR will initiate FT218 treatment at a dose equivalent or closest to the total gram dose of twice-nightly sodium oxybate IR and then titrate up or down, in accord with safety and effectiveness as determined by the investigator. ;

Related Conditions & MeSH terms

• Cataplexy
• Disorders of Excessive Somnolence
• Dyssomnias
• Excessive Daytime Somnolence
• Narcolepsy
• Parasomnias
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders
• Sleepiness

• NCT number: NCT04451668
• Study type: Interventional
• Source: Avadel
• Status: Completed
• Phase: Phase 3
• Start date: June 12, 2020
• Completion date: December 22, 2023