An Open Label Study of FT218 in Subjects With Narcolepsy (RESTORE)

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

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

Study Overview

• Status: Completed
• Conditions: Sleep Wake Disorders; Sleep Disorder; Sleep Disturbance; Narcolepsy; Cataplexy; Excessive Daytime Somnolence
• Intervention / Treatment: Drug: FT218

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Parry Sound, Ontario, Canada, P2A 3A4
      • West Perry Sound Health Center
    • Toronto, Ontario, Canada, M5S 3A3
      • Jodha Tishon Inc.
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Sleep Disorders Center of Alabama
  • California
    • Redwood City, California, United States, 94063
      • Stanford Sleep Medicine
    • Santa Ana, California, United States, 92705
      • SDS Clinical Trials
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center
    • Colorado Springs, Colorado, United States, 80918
      • Delta Waves, Inc.
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Pulmonary Disease Specialists, PA
    • Miami, Florida, United States, 33176
      • Sleep Medicine Specialists of South Florida
    • Winter Park, Florida, United States, 32789
      • FL Pediatric Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • NeuroTrials Research Inc
    • Stockbridge, Georgia, United States, 30281
      • SleepCare Research Institute, Inc. d/b/a Clinical Research Institute
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Neurological
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Helene A. Emsellem, MD PC
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Luke's Hospital - Sleep Medicine and Research Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Sleep-Wake Disorders Center
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Advanced Respiratory and Sleep Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Sleep Management Institute Intrepid Research
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine Institute
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Malvern, Pennsylvania, United States, 19355
      • Brian Abaluck Sleep Medicine
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants, LLC
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • San Antonio, Texas, United States, 78229-4849
      • Sleep Therapy & Research Center
    • Sugar Land, Texas, United States, 77478
      • Comprehensive Sleep Medicine Associates
    • Tomball, Texas, United States, 77375
      • Northwest Houston Neurology
  • Virginia
    • Williamsburg, Virginia, United States, 23188
      • TPMG Clinical Research Williamsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FT218; once nightly sodium oxybate extended release oral solution (FT218)	Drug: FT218; once nightly sodium oxybate extended release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Avadel

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Neurologic Manifestations; Sleep Wake Disorders; Dyssomnias; Parasomnias; Disorders of Excessive Somnolence; Sleepiness; Narcolepsy; Cataplexy
• Other Study ID Numbers: CLFT218-1901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No