Excessive Daytime SleepinessPhase 3NCT02720744

Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

A Phase 3 study testing FT218 in people with Excessive Daytime Sleepiness and Cataplexy, run by Avadel at 57 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
What is being tested?: FT218
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 212 participants
Where: 57 sitesin 6 countries
Study dates: 17 Nov 2016to 25 Mar 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male or female subjects 16 years of age or older
Willing and able to give written informed consent for study participation. For young adults (16 and 17 years old) who have not reached the age of majority they must be capable of giving assent and consent from a legally authorized guardian must be obtained, as required by local laws and regulations
Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2 narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with mean sleep latency in the pathological range i.e. < 8 minutes and meeting the NT1 and NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
Current continuing presence of EDS (excessive daytime sleepiness) as defined by subject report for the last 3 months and an ESS (Epworth sleepiness scale) > 10
For NT1 only, current continuing presence of cataplexy as defined by subject report for the last 3 months
Subjects may use concomitant stimulants, but must comply with the following:

Show all 10Show fewer

They must be on a stable dose of stimulants for at least 3 weeks prior to starting the screening process for this study; AND
They must use the same stimulant regimen throughout the entire study period, including during screening and posttreatment periods
They must discontinue all anti cataplexy drugs
Addition inclusion criteria per protocol

Who cannot join

Any prior use of sodium oxybate is allowed in the study but within the following exclusions:
Previous dosing must have been limited to no more than 4.5g per night
Patient should not have taken sodium oxybate for more than 2 weeks.
All previous dosing must not have occurred within the last year prior to entry to the study.
Current use of sodium valproate
Any use of the following prohibited medications for the duration of the clinical study:

Show all 19Show fewer

Anticonvulsants
Clonidine
SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine re-uptake inhibitors (SNRIs)
MAOIs (monoamine oxidase inhibitors)
TCAs (tricyclic antidepressants)
Hypnotics
Anxiolytics
Sedating antihistamines
Antipsychotics
Other experimental medications designed to treat narcolepsy, cataplexy or any other condition
Treatment with any investigational products within 3 months before study enrollment
Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
Additional exclusion criteria per protocol

Trial locations and contacts

57 sites in 6 countries.

Country

City, postcode or hospital

57 sites in 6 countries

United States38 sites

California Center for Sleep Disorders
Alameda, California, 94501
Pinnacle Research Group LLC
Anniston, Alabama, 36207
NeuroTrials Research Inc
Atlanta, Georgia, 30342
Sleep Disorders Center of Georgia
Atlanta, Georgia, GA 30342
University Sleep Disorder Center
Auburn, Alabama, AL 36832
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Alpine Research Center
Boulder, Colorado, 80301
Medical University of South Carolina - Institute of Psychiatry
Charleston, South Carolina, SC 29425
Study site
Chesterfield, Missouri, 63017
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
Sleep Management Institute Intrepid Research
Cincinnati, Ohio, 45245
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
SleepMed Of South Carolina
Columbia, South Carolina, 29201
Geisinger Medical Center
Danville, Pennsylvania, 17822
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
Fort Wayne Neurological Center
Fort Wayne, Indiana, IN 46804
Sleep and Neurology Consultants
Houston, Texas, 77063
Research Carolina of Huntersville
Huntersville, North Carolina, 28078
Pulmonary Disease Specialist, PA
Kissimmee, Florida, 34741
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Norton Clinical Research Group
Louisville, Kentucky, KY40218
Sleep Medicine Specialists of South Florida
Miami, Florida, 33176
Sleep Medicine Specialist of South Florida
Miami, Florida, FL 33126
Northwell Health
New Hyde Park, New York, NY 1040
Clinilabs Drug Development Corporation
New York, New York, NY10019
Infinity Medical Research
North Dartmouth, Massachusetts, MA 2747
Yale-New Haven Hospital's Sleep Medicine Center
North Haven, Connecticut, 06473
NeuroMedical Research Institute/Global Research Holdings, LLC
Panama City, Florida, FL 32405
OSF Healthcare Saint Francis Medical Center
Peoria, Illinois, 61637
Wake Research Associates, LLC
Raleigh, North Carolina, NC 27612
Stanford Sleep Medicine
Redwood City, California, 94063
Sleep Therapy Research Center
San Antonio, Texas, 78229
SDS Clinical Trials Inc
Santa Ana, California, CA 92705
Study site
St Louis, Missouri, 63143
Clinical Research Institute
Stockbridge, Georgia, 30281
Montefiore Sleep-Wake Disorders Center
The Bronx, New York, 10467
FL Pediatric REsearch Institute
Winter Park, Florida, 32789
Florida Pulmonary Research Institute LLC
Winter Park, Florida, 32789

Other trials in United States

Australia6 sites

Queen Elizabeth Hospital
Adelaide, South Australia, SA 5011
Flinders Medical Centre
Adelaide, South Australia, SA 5042
Princess Alexandra Hospital
Brisbane, Queensland, QLD 4102
Melbourne Sleep Disorders Centre
Melbourne, Victoria, 3002
NHMRC CEntre for Translational Sleep and Circadian Neurobiology
Sydney, New South Wales, 2037
Westmead Hospital
Sydney, New South Wales, NSW 2145

Other trials in Australia

Canada6 sites

Somni Research Inc. Calgary
Calgary, Alberta, T2X 2A8
Okanagan Clinical Trials Ltd
Kelowna, British Columbia, BC V1Y 1Z9
CIUSS de Nord-de-I'ile-de- Montreal- Hopital de Sacre-Coeur de Montreal
Montreal, Quebec, 5400
West Parry Sound Health Center
Parry Sound, Ontario, P2A 3A4
Somni Research Inc
Toronto, Ontario, L3R 1A3
Paediatric Sleep Research Inc
Toronto, Ontario, M5G 1N8

Other trials in Canada

France3 sites

CHU Michallon
Grenoble, 938043
Hospital Gui-de-de-Chauliac
Montpellier, 34295
INSERM - Centre d'Investigation Clinque Hopital Robert Debre
Paris, 75019

Other trials in France

Germany3 sites

Charit Universittsmedizin Berlin
Berlin, 10117
Hephata Klinik
Schwalmstadt, 34131
Somni bene GmbH
Schwerin, 19053

Other trials in Germany

Czechia1 site

Vseobecna Facultni Nemocnice
Prague, 212821

Other trials in Czechia

About this study

Official title: A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy

The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

Conditions: Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
Being tested: FT218, Placebo
Medical subject headings: Disorders of Excessive Somnolence, Cataplexy, Narcolepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FT218Drug
PlaceboDrug

Study groups in NCT02720744
Study group	Role	What they receive
Sodium Oxybate	Experimental	Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g sodium oxybate, 6.0 g sodium oxybate, 7.5 g sodium oxybate, and 9.0 g sodium oxybate. Receives: Drug: FT218
Placebo	Placebo comparator	Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g placebo, 6.0 g placebo, 7.5 g placebo, and 9.0 g placebo. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maintenance of Wakefulness Test (MWT)
Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day
Measured: Study Visit 8 at 14 weeks
Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening
The CGI is the clinician's global impression of improvement in daytime sleepiness. For the CGI, a GLIMMIX (generalized linear mixed models) model for binomial data with logit link was used to analyze the categorized CGI response, i.e., the proportions of subjects who were Very Much Improved or Much Improved as compared to Screening
Measured: Study Visit 8 at 14 weeks
Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline
Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period
Measured: Visit 8 - Change from Baseline at 14 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 201625 Mar 2020

First posted28 Mar 2016 (estimated)
Study start17 Nov 2016
Primary completion25 Mar 2020
Study completion25 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Excessive Daytime SleepinessStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 212 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02720744
Sponsor's protocol ID: CLFT218-1501
Status last verified: Mar 2022
First submitted: 22 Mar 2016
Last updated: 22 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ortiz LE, Morse AM, Thorpy MJ, Kushida CA, Harsh J, Roth T, Gudeman J, Dauvilliers Y. Once-Nightly Sodium Oxybate Meets American Academy of Sleep Medicine Criteria for Treatment of Narcolepsy. J Sleep Res. 2026 Apr;35(2):e70189. doi: 10.1111/jsr.70189. Epub 2025 Aug 25.
PubMed 40851446
Roth T, Thorpy MJ, Kushida CA, Gudeman J. Efficacy of Once-Nightly Sodium Oxybate in Patients with Narcolepsy: Post Hoc Analyses of Sensitivity, Effect Size, and Numbers Needed to Treat from the Phase 3 REST-ON Trial. CNS Drugs. 2025 Mar;39(Suppl 1):61-70. doi: 10.1007/s40263-025-01160-0. Epub 2025 Mar 20.
PubMed 40111739
Krahn L, Roy A, Winkelman JW, Morse AM, Gudeman J. Assessing Early Efficacy After Initiation of Once-Nightly Sodium Oxybate (ON-SXB; FT218) in Participants with Narcolepsy Type 1 or 2: A Post Hoc Analysis from the Phase 3 REST-ON Trial. CNS Drugs. 2025 Mar;39(Suppl 1):53-59. doi: 10.1007/s40263-024-01143-7. Epub 2025 Mar 20.
PubMed 40111738
Dauvilliers Y, Roth T, Bogan R, Thorpy MJ, Morse AM, Roy A, Gudeman J. Efficacy of once-nightly sodium oxybate (FT218) on daytime symptoms in individuals with narcolepsy with or without concomitant alerting agent use: A post hoc analysis from the phase 3 REST-ON trial. Sleep Med. 2024 Dec;124:209-216. doi: 10.1016/j.sleep.2024.09.024. Epub 2024 Sep 17.
PubMed 39321628
Roth T, Morse AM, Bogan R, Roy A, Gudeman J, Dauvilliers Y. Weight Loss With Once-nightly Sodium Oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial. Clin Ther. 2024 Oct;46(10):791-798. doi: 10.1016/j.clinthera.2024.07.010. Epub 2024 Aug 16.
PubMed 39153911
Roth T, Dauvilliers Y, Thorpy MJ, Kushida C, Corser BC, Bogan R, Rosenberg R, Dubow J, Seiden D. Effect of FT218, a Once-Nightly Sodium Oxybate Formulation, on Disrupted Nighttime Sleep in Patients with Narcolepsy: Results from the Randomized Phase III REST-ON Trial. CNS Drugs. 2022 Apr;36(4):377-387. doi: 10.1007/s40263-022-00904-6. Epub 2022 Apr 5.
PubMed 35380374
Kushida CA, Shapiro CM, Roth T, Thorpy MJ, Corser BC, Ajayi AO, Rosenberg R, Roy A, Seiden D, Dubow J, Dauvilliers Y. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Sleep. 2022 Jun 13;45(6):zsab200. doi: 10.1093/sleep/zsab200.
PubMed 34358324

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Excessive Daytime Sleepiness trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy
ClinicalTrials.gov ID: NCT02720744
Acronym / sponsor ID: CLFT218-1501
Conditions: Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 212 participants (actual)
Lead sponsor: AvadelIndustry (pharma, biotech, devices)
Study start: 17 Nov 2016 (actual)
Primary completion: 25 Mar 2020 (actual)
Study completion: 25 Mar 2020 (actual)
First posted: 28 Mar 2016 (estimated)
Results: Posted 22 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Sodium Oxybate	Experimental	Drug: FT218Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g sodium oxybate, 6.0 g sodium oxybate, 7.5 g sodium oxybate, and 9.0 g sodium oxybate.
Placebo	Placebo comparator	Drug: PlaceboPatients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g placebo, 6.0 g placebo, 7.5 g placebo, and 9.0 g placebo.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

Male or female subjects 16 years of age or older
Willing and able to give written informed consent for study participation. For young adults (16 and 17 years old) who have not reached the age of majority they must be capable of giving assent and consent from a legally authorized guardian must be obtained, as required by local laws and regulations
Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2 narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with mean sleep latency in the pathological range i.e. < 8 minutes and meeting the NT1 and NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
Current continuing presence of EDS (excessive daytime sleepiness) as defined by subject report for the last 3 months and an ESS (Epworth sleepiness scale) > 10
For NT1 only, current continuing presence of cataplexy as defined by subject report for the last 3 months

Key exclusion criteria (19 listed)

Any prior use of sodium oxybate is allowed in the study but within the following exclusions:
Current use of sodium valproate
Any use of the following prohibited medications for the duration of the clinical study:
Treatment with any investigational products within 3 months before study enrollment
Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted

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
FT218	Drug	Sodium Oxybate
Placebo	Drug	Placebo

Primary outcome

Maintenance of Wakefulness Test (MWT)
Time frame: Study Visit 8 at 14 weeks
Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day
Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening
Time frame: Study Visit 8 at 14 weeks
The CGI is the clinician's global impression of improvement in daytime sleepiness. For the CGI, a GLIMMIX (generalized linear mixed models) model for binomial data with logit link was used to analyze the categorized CGI response, i.e., the proportions of subjects who were Very Much Improved or Much Improved as compared to Screening
Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline
Time frame: Visit 8 - Change from Baseline at 14 Weeks
Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period

Results and safety

Results posted to the registry on 22 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FT218	107	69
Placebo	105	79

Primary outcome: Maintenance of Wakefulness Test (MWT)

Time frame: Study Visit 8 at 14 weeks. Mean (Standard Deviation). Unit: minutes

Measure	FT218 n = 68	Placebo n = 78
Value	10.8 (0.96)	4.7 (0.92)

FT218 vs Placebo: Mean Difference (Net): 6.13 (95% CI 3.52 to 8.75), p <0.001, Mixed Models Analysis

Population analysed: Maintenance of Wakefulness Test (MWT) Mean Sleep Latency (Minutes) Change from Baseline to the End of the 9.0g Treatment Period - MMRM (mixed model repeat measure) Analysis (mITT Population)

Primary outcome: Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening

Time frame: Study Visit 8 at 14 weeks. Number. Unit: percentage of subjects

Measure	FT218 n = 69	Placebo n = 79
Value	72.0	31.6

FT218 vs Placebo: Odds Ratio (OR): 5.56 (95% CI 2.76 to 11.23), p <0.001, GLIMMIX model

Population analysed: Clinical Global Impression - Improvement (CGI-I) by the End of 9.0g Treatment Period

Primary outcome: Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline

Time frame: Visit 8 - Change from Baseline at 14 Weeks. Mean (Standard Deviation). Unit: Cataplexy Attacks

Measure	FT218 n = 54	Placebo n = 62
Value	-11.5 (0.96)	-4.9 (0.95)

FT218 vs Placebo: Mean Difference (Net): -6.65 (95% CI -9.32 to -3.98), p <0.001, Mixed Models Analysis

Population analysed: Mean Weekly Number of Cataplexy Attacks (NCA) of Each Dosing Period, Change from Baseline to the End of 9.0g Treatment Period - MMRM Analysis (NT1 Subjects in mITT Population)

Adverse events

Time frame: AE (adverse event) data were obtained at all study visits (scheduled or unscheduled) from the time of the signing of informed consent until seven days after the last dose of study drug, at 14 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FT218 9g Group	1 of 77 (1.3%)	23 of 77 (29.9%)	0 of 77
Placebo 9g Group	0 of 80 (0%)	6 of 80 (7.5%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40851446Ortiz LE, Morse AM, Thorpy MJ, Kushida CA, Harsh J, Roth T, Gudeman J, Dauvilliers Y. Once-Nightly Sodium Oxybate Meets American Academy of Sleep Medicine Criteria for Treatment of Narcolepsy. J Sleep Res. 2026 Apr;35(2):e70189. doi: 10.1111/jsr.70189. Epub 2025 Aug 25.
Derived from this study: PubMed 40111739Roth T, Thorpy MJ, Kushida CA, Gudeman J. Efficacy of Once-Nightly Sodium Oxybate in Patients with Narcolepsy: Post Hoc Analyses of Sensitivity, Effect Size, and Numbers Needed to Treat from the Phase 3 REST-ON Trial. CNS Drugs. 2025 Mar;39(Suppl 1):61-70. doi: 10.1007/s40263-025-01160-0. Epub 2025 Mar 20.
Derived from this study: PubMed 40111738Krahn L, Roy A, Winkelman JW, Morse AM, Gudeman J. Assessing Early Efficacy After Initiation of Once-Nightly Sodium Oxybate (ON-SXB; FT218) in Participants with Narcolepsy Type 1 or 2: A Post Hoc Analysis from the Phase 3 REST-ON Trial. CNS Drugs. 2025 Mar;39(Suppl 1):53-59. doi: 10.1007/s40263-024-01143-7. Epub 2025 Mar 20.
Derived from this study: PubMed 39321628Dauvilliers Y, Roth T, Bogan R, Thorpy MJ, Morse AM, Roy A, Gudeman J. Efficacy of once-nightly sodium oxybate (FT218) on daytime symptoms in individuals with narcolepsy with or without concomitant alerting agent use: A post hoc analysis from the phase 3 REST-ON trial. Sleep Med. 2024 Dec;124:209-216. doi: 10.1016/j.sleep.2024.09.024. Epub 2024 Sep 17.
Derived from this study: PubMed 39153911Roth T, Morse AM, Bogan R, Roy A, Gudeman J, Dauvilliers Y. Weight Loss With Once-nightly Sodium Oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial. Clin Ther. 2024 Oct;46(10):791-798. doi: 10.1016/j.clinthera.2024.07.010. Epub 2024 Aug 16.
Derived from this study: PubMed 35380374Roth T, Dauvilliers Y, Thorpy MJ, Kushida C, Corser BC, Bogan R, Rosenberg R, Dubow J, Seiden D. Effect of FT218, a Once-Nightly Sodium Oxybate Formulation, on Disrupted Nighttime Sleep in Patients with Narcolepsy: Results from the Randomized Phase III REST-ON Trial. CNS Drugs. 2022 Apr;36(4):377-387. doi: 10.1007/s40263-022-00904-6. Epub 2022 Apr 5.
Derived from this study: PubMed 34358324Kushida CA, Shapiro CM, Roth T, Thorpy MJ, Corser BC, Ajayi AO, Rosenberg R, Roy A, Seiden D, Dubow J, Dauvilliers Y. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Sleep. 2022 Jun 13;45(6):zsab200. doi: 10.1093/sleep/zsab200.

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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.

57 sites in 6 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 Excessive Daytime Sleepiness and Cataplexy, run by Avadel at 57 sites in 6 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 10 inclusion and 19 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Australia, Canada, France, Germany and 1 more country. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 22 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maintenance of Wakefulness Test (MWT) (time frame: Study Visit 8 at 14 weeks). 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 NCT02720744, which also lists 7 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 22 Mar 2022.