NarcolepsyPhase 3RESTORENCT04451668
An Open Label Study of FT218 in Subjects With Narcolepsy
A Phase 3 study testing FT218 in people with Narcolepsy and Cataplexy, run by Avadel at 29 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Narcolepsy, Cataplexy, Excessive Daytime Somnolence
- What is being tested?
- FT218
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 12 Jun 2020to 18 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States27 sites
NeuroTrials Research Inc
Atlanta, Georgia, 30328
FutureSearch Trials of Neurology
Austin, Texas, 78731
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Alpine Clinical Research Center
Boulder, Colorado, 80301
St. Luke's Hospital - Sleep Medicine and Research Center
Chesterfield, Missouri, 63017
Helene A. Emsellem, MD PC
Chevy Chase, Maryland, 20815
Sleep Management Institute Intrepid Research
Cincinnati, Ohio, 45245
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Delta Waves, Inc.
Colorado Springs, Colorado, 80918
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Geisinger Medical Center
Danville, Pennsylvania, 17822
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
Fort Wayne Neurological
Fort Wayne, Indiana, 46804
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, 28078
Pulmonary Disease Specialists, PA
Kissimmee, Florida, 34741
Brian Abaluck Sleep Medicine
Malvern, Pennsylvania, 19355
Sleep Medicine Specialists of South Florida
Miami, Florida, 33176
Stanford Sleep Medicine
Redwood City, California, 94063
Sleep Therapy & Research Center
San Antonio, Texas, 78229-4849
SDS Clinical Trials
Santa Ana, California, 92705
Baystate Medical Center
Springfield, Massachusetts, 01199
SleepCare Research Institute, Inc. d/b/a Clinical Research Institute
Stockbridge, Georgia, 30281
Comprehensive Sleep Medicine Associates
Sugar Land, Texas, 77478
Montefiore Sleep-Wake Disorders Center
The Bronx, New York, 10467
Northwest Houston Neurology
Tomball, Texas, 77375
TPMG Clinical Research Williamsburg
Williamsburg, Virginia, 23188
FL Pediatric Research Institute
Winter Park, Florida, 32789
Canada2 sites
West Perry Sound Health Center
Parry Sound, Ontario, P2A 3A4
Jodha Tishon Inc.
Toronto, Ontario, M5S 3A3
About this study
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
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
Read the 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.
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder, Sleep Disturbance, Sleep Wake Disorders
- Being tested
- FT218
- Medical subject headings
- Narcolepsy, Cataplexy, Disorders of Excessive Somnolence, Sleep Wake Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT218Drug
once nightly sodium oxybate extended release
| Study group | Role | What they receive |
|---|---|---|
| FT218 | Experimental | once nightly sodium oxybate extended release oral solution (FT218) Receives: Drug: FT218 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start12 Jun 2020
- Primary completion22 Dec 2023
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label treatment with FT218 (once nightly sodium oxybate extended release)
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avadel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451668
- Sponsor's protocol ID
- CLFT218-1901
- Acronym
- RESTORE
- Status last verified
- Sep 2025
- First submitted
- 23 Jun 2020
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roy A, Stern T, Harsh J, Corser BC, Santamaria A, Abaluck B, Ibrahim S, Lancaster K, Gudeman J. Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates: a plain language summary of publication. Expert Rev Neurother. 2026 Jul;26(7):701-711. doi: 10.1080/14737175.2026.2668473. Epub 2026 May 20.
PubMed 42163487Roy 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.
PubMed 39263597
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04451668
- Acronym / sponsor ID
- RESTORE / CLFT218-1901
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder, Sleep Disturbance, Sleep Wake Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- AvadelIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label treatment with FT218 (once nightly sodium oxybate extended release)
| Arm | Type | Receives |
|---|---|---|
| FT218 | Experimental | Drug: FT218once nightly sodium oxybate extended release oral solution (FT218) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT218once nightly sodium oxybate extended release | Drug | FT218 |
Primary outcome
Incidence of treatment-related adverse events
Time frame: 24 months
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events
Incidence of clinically significant changes in vital signs
Time frame: 24 months
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in vital signs
Incidence of clinically significant changes in laboratory test results
Time frame: 24 months
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in laboratory test results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 42163487Roy A, Stern T, Harsh J, Corser BC, Santamaria A, Abaluck B, Ibrahim S, Lancaster K, Gudeman J. Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates: a plain language summary of publication. Expert Rev Neurother. 2026 Jul;26(7):701-711. doi: 10.1080/14737175.2026.2668473. Epub 2026 May 20.
- Derived from this study: PubMed 39263597Roy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FT218 in people with Narcolepsy and Cataplexy, run by Avadel at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse events (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04451668, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.