An Open Label Study of FT218 in Subjects With Narcolepsy

NCT04451668 | Completed Phase 3 FDA Drug

• 1 other identifier: CLFT218-1901
• Study Type: interventional
• Target: 184
• Locations: 2 countries
• Sites: 29

Brief 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

Conditions

Narcolepsy; Cataplexy; Excessive Daytime Somnolence; Sleep Disorder; Sleep Disturbance; Sleep Wake Disorders

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

FT218

EXPERIMENTAL

once nightly sodium oxybate extended release oral solution (FT218)

Drug: FT218

Interventions

FT218 DRUG

once nightly sodium oxybate extended release

FT218

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avadel: lead

Study Sites (29)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Stanford Sleep Medicine

Redwood City, California, 94063, United States

Location

SDS Clinical Trials

Santa Ana, California, 92705, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80301, United States

Location

Delta Waves, Inc.

Colorado Springs, Colorado, 80918, United States

Location

Pulmonary Disease Specialists, PA

Kissimmee, Florida, 34741, United States

Location

Sleep Medicine Specialists of South Florida

Miami, Florida, 33176, United States

Location

FL Pediatric Research Institute

Winter Park, Florida, 32789, United States

Location

NeuroTrials Research Inc

Atlanta, Georgia, 30328, United States

Location

SleepCare Research Institute, Inc. d/b/a Clinical Research Institute

Stockbridge, Georgia, 30281, United States

Location

Fort Wayne Neurological

Fort Wayne, Indiana, 46804, United States

Location

Helene A. Emsellem, MD PC

Chevy Chase, Maryland, 20815, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

St. Luke's Hospital - Sleep Medicine and Research Center

Chesterfield, Missouri, 63017, United States

Location

Montefiore Sleep-Wake Disorders Center

The Bronx, New York, 10467, United States

Location

Advanced Respiratory and Sleep Medicine

Huntersville, North Carolina, 28078, United States

Location

Sleep Management Institute Intrepid Research

Cincinnati, Ohio, 45245, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Brian Abaluck Sleep Medicine

Malvern, Pennsylvania, 19355, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229-4849, United States

Location

Comprehensive Sleep Medicine Associates

Sugar Land, Texas, 77478, United States

Location

Northwest Houston Neurology

Tomball, Texas, 77375, United States

Location

TPMG Clinical Research Williamsburg

Williamsburg, Virginia, 23188, United States

Location

West Perry Sound Health Center

Parry Sound, Ontario, P2A 3A4, Canada

Location

Jodha Tishon Inc.

Toronto, Ontario, M5S 3A3, Canada

Location

Related Publications (1)

• Roy A, Stern T, Harsh J, Hudson JD, Ajayi AO, Corser BC, Mignot E, Santamaria A, Morse AM, Abaluck B, Ibrahim S, Schweitzer PK, Lancaster K, Dubow J, Gudeman J. RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates. Sleep Med X. 2024 Aug 15;8:100122. doi: 10.1016/j.sleepx.2024.100122. eCollection 2024 Dec 15.

  PMID: 39263597 DERIVED

MeSH Terms

Conditions

Narcolepsy; Cataplexy; Disorders of Excessive Somnolence; Sleep Wake Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label treatment with FT218 (once nightly sodium oxybate extended release)

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 30, 2020
• Study Start: June 12, 2020
• Primary Completion: December 22, 2023
• Study Completion: November 18, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (27)