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New Once-Nightly pill could simplify narcolepsy treatment

NCT ID NCT04451668

Symptom relief Sponsor: Avadel Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new once-nightly medication called FT218 for people with narcolepsy who experience excessive daytime sleepiness and sudden muscle weakness (cataplexy). It included 184 participants, some already on a twice-nightly medication and some new to treatment. The goal was to see if FT218 is safe and tolerable over the long term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

184 people

The number who actually took part.

Started

Jun 2020

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Cataplexy Disorders of Excessive Somnolence hypersomnia narcolepsy narcolepsy 1 Parasomnias sleep disorder sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cataplexy Excessive daytime somnolence Narcolepsy Sleep disorder Sleep disturbance Sleep wake disorders

Contacts and locations

Locations

  • Advanced Respiratory and Sleep Medicine

    Huntersville, North Carolina, 28078, United States

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301, United States

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201, United States

  • Brian Abaluck Sleep Medicine

    Malvern, Pennsylvania, 19355, United States

  • Comprehensive Sleep Medicine Associates

    Sugar Land, Texas, 77478, United States

  • Delta Waves, Inc.

    Colorado Springs, Colorado, 80918, United States

  • FL Pediatric Research Institute

    Winter Park, Florida, 32789, United States

  • Fort Wayne Neurological

    Fort Wayne, Indiana, 46804, United States

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Helene A. Emsellem, MD PC

    Chevy Chase, Maryland, 20815, United States

  • Jodha Tishon Inc.

    Toronto, Ontario, M5S 3A3, Canada

  • Montefiore Sleep-Wake Disorders Center

    The Bronx, New York, 10467, United States

  • NeuroTrials Research Inc

    Atlanta, Georgia, 30328, United States

  • Northwest Houston Neurology

    Tomball, Texas, 77375, United States

  • Ohio Sleep Medicine Institute

    Dublin, Ohio, 43017, United States

  • Pulmonary Disease Specialists, PA

    Kissimmee, Florida, 34741, United States

  • SDS Clinical Trials

    Santa Ana, California, 92705, United States

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama, 35213, United States

  • Sleep Management Institute Intrepid Research

    Cincinnati, Ohio, 45245, United States

  • Sleep Medicine Specialists of South Florida

    Miami, Florida, 33176, United States

  • Sleep Therapy & Research Center

    San Antonio, Texas, 78229-4849, United States

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

    Stockbridge, Georgia, 30281, United States

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

    Chesterfield, Missouri, 63017, United States

  • Stanford Sleep Medicine

    Redwood City, California, 94063, United States

  • TPMG Clinical Research Williamsburg

    Williamsburg, Virginia, 23188, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • West Perry Sound Health Center

    Parry Sound, Ontario, P2A 3A4, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.