An Open Label Study of FT218 in Subjects With Narcolepsy

Sleep Disturbance Clinical Trial

— RESTORE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451668
• Other study ID #: CLFT218-1901
• Status: Completed
• Phase: Phase 3
• Start date: June 12, 2020
• Est. completion date: December 22, 2023

Study information

• Verified date: January 2024
• Source: Avadel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Subjects receiving a stable doses of twice-nightly sodium oxybate IR or mixed salts oxybate for at least 4 weeks and are willing to switch to FT218
• Subjects who completed the CLFT218-1501 REST-ON Study in a compliant manner and for whom the Investigator determines would receive benefit from treatment with FT218 and have not started treatment with twice nightly sodium oxybate IR or mixed salts oxybate
• Are treatment naïve to any oxybate therapy (i.e. FT218, twice nightly sodium oxybate IR or mixed salts oxybate)
• Subjects have a diagnosis of narcolepsy, either confirmed prior to the REST-ON study or as confirmed by the Investigator as defined by the International Classification of Sleep Disorders 3 criteria (AASM 2014)
• Willing and able to give written informed consent for study participation. Young adults (16 and 17 years old) who have not reached the age of majority must be capable of giving assent in addition to consent from a legally authorized guardian, as required by local laws and regulations.

Exclusion Criteria:

• Subjects that terminated the CLFT218-1501 REST-ON Study prior to completing Visit 8
• Any use of the following medications during the study: Anticonvulsants, Clonidine, Hypnotics, Anxiolytics, Sedating antihistamines, Antipsychotics, Other experimental medications designed to treat narcolepsy, cataplexy or any other condition, or other medications with significant sedating effects/CNS depressant effects are prohibited for REST-ON and naive patients. Patients on twice nightly sodium oxybate IR on medications in classes listed above may be eligible for enrollment if the subject has been on a stable dose of the prohibited medication in combination with a stable dose of twice nightly sodium oxybate or mixed salts oxybate for at least three months and has demonstrated no AEs, intolerance, or interactions AND is approved to participate by the Medical Monitor. Sedative hypnotics are prohibited regardless.)
• A diagnosis of sleep apnea where AHI is =15 and/or current use of CPAP or other devices for sleep apnea.

Related Conditions & MeSH terms

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

Intervention

Drug:
• FT218
once nightly sodium oxybate extended release

Locations

Country	Name	City	State
Canada	West Perry Sound Health Center	Parry Sound	Ontario
Canada	Jodha Tishon Inc.	Toronto	Ontario
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Montefiore Sleep-Wake Disorders Center	Bronx	New York
United States	St. Luke's Hospital - Sleep Medicine and Research Center	Chesterfield	Missouri
United States	Helene A. Emsellem, MD PC	Chevy Chase	Maryland
United States	Sleep Management Institute Intrepid Research	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Delta Waves, Inc.	Colorado Springs	Colorado
United States	Bogan Sleep Consultants, LLC	Columbia	South Carolina
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Ohio Sleep Medicine Institute	Dublin	Ohio
United States	Fort Wayne Neurological	Fort Wayne	Indiana
United States	Advanced Respiratory and Sleep Medicine	Huntersville	North Carolina
United States	Pulmonary Disease Specialists, PA	Kissimmee	Florida
United States	Brian Abaluck Sleep Medicine	Malvern	Pennsylvania
United States	Sleep Medicine Specialists of South Florida	Miami	Florida
United States	Stanford Sleep Medicine	Redwood City	California
United States	Sleep Therapy & Research Center	San Antonio	Texas
United States	SDS Clinical Trials	Santa Ana	California
United States	Baystate Medical Center	Springfield	Massachusetts
United States	SleepCare Research Institute, Inc. d/b/a Clinical Research Institute	Stockbridge	Georgia
United States	Comprehensive Sleep Medicine Associates	Sugar Land	Texas
United States	Northwest Houston Neurology	Tomball	Texas
United States	TPMG Clinical Research Williamsburg	Williamsburg	Virginia
United States	FL Pediatric Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Avadel

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-related adverse events	Assess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events	24 months
Primary	Incidence of clinically significant changes in vital signs	Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in vital signs	24 months
Primary	Incidence of clinically significant changes in laboratory test results	Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in laboratory test results	24 months