A Phase 3 interventional study of FT218 and Placebo in Excessive Daytime Sleepiness, Cataplexy and Narcolepsy, sponsored by Avadel. Completed at 57 sites in 6 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by Avadel (part of Alkermes, Inc.) · Phase 3, Interventional, and Treatment
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.
31 studies on the registry are indexed under Cataplexy; 5 are open to participants now.
This study's enrollment of 212 is above the median of 117 across 27 interventional studies indexed under Cataplexy.
Browse Cataplexy studies →Avadel is the lead sponsor of 4 studies on the registry; none are open to participants now.
First submitted before Avadel became part of Alkermes, Inc..
Compared within Cataplexy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disorders of Excessive Somnolence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects may use concomitant stimulants, but must comply with the following:
Exclusion criteria
Any prior use of sodium oxybate is allowed in the study but within the following exclusions:
Any use of the following prohibited medications for the duration of the clinical study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: FT218
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.
Drug: Placebo
Maintenance of Wakefulness Test (MWT)
Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day
Time frame: 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
Time frame: 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
Time frame: Visit 8 - Change from Baseline at 14 Weeks
| Milestone | FT218 | Placebo |
|---|---|---|
| Started | 107 | 105 |
| Completed | 69 | 79 |
| Not completed | 38 | 26 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Pregnancy | 2 | 0 |
| Withdrew: Lack of efficacy | 2 | 8 |
| Withdrew: Adverse event | 21 | 3 |
| Withdrew: Withdrawal by subject | 11 | 11 |
| Withdrew: Lost to follow up | 2 | 0 |
| Withdrew: Non compliance with investigational product | 0 | 1 |
| Withdrew: Excluded concomitant medication | 0 | 1 |
Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day
| minutes | FT218 | Placebo |
|---|---|---|
| Maintenance of Wakefulness Test (MWT) | 10.8 ± 0.96 | 4.7 ± 0.92 |
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
| percentage of subjects | FT218 | Placebo |
|---|---|---|
| Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening | 72.0 | 31.6 |
Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period
| Cataplexy Attacks | FT218 | Placebo |
|---|---|---|
| Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline | -11.5 ± 0.96 | -4.9 ± 0.95 |
Collected over 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.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FT218 9g Group | 0/77 (0%) | 1/77 (1.3%) | 23/77 (29.9%) |
| Placebo 9g Group | 0/80 (0%) | 0/80 (0%) | 6/80 (7.5%) |
| Event | FT218 9g Group | Placebo 9g Group |
|---|---|---|
| Suicidal ideationPsychiatric disorders | 1/77 | 0/80 |
| Event | FT218 9g Group | Placebo 9g Group |
|---|---|---|
| EnuresisPsychiatric disorders | 7/77 | 0/80 |
| DizzinessNervous system disorders | 4/77 | 0/80 |
| VomitingGastrointestinal disorders | 4/77 | 0/80 |
| SomnolenceNervous system disorders | 3/77 | 0/80 |
| Weight DecreasedMetabolism and nutrition disorders | 3/77 | 0/80 |
| HeadacheNervous system disorders | 3/77 | 3/80 |
| NauseaGastrointestinal disorders | 3/77 | 1/80 |
| Decreased AppetiteMetabolism and nutrition disorders | 2/77 | 0/80 |
| NasopharyngitisInfections and infestations | 2/77 | 2/80 |
| Age, Categorical(Participants) | FT218 | Placebo | Total |
|---|---|---|---|
| <=18 years | 9 | 12 | 21 |
| Between 18 and 65 years | 97 | 91 | 188 |
| >=65 years | 1 | 2 | 3 |
| Age, Continuous(years) | FT218 | Placebo | Total |
|---|---|---|---|
| Mean | 30.9 ± 10.70 | 31.6 ± 11.24 | 31.2 ± 10.95 |
| Sex: Female, Male(Participants) | FT218 | Placebo | Total |
|---|---|---|---|
| Female | 69 | 75 | 144 |
| Male | 38 | 30 | 68 |
| Race (NIH/OMB)(Participants) | FT218 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 8 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 21 | 15 | 36 |
| White | 80 | 80 | 160 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(Participants) | FT218 | Placebo | Total |
|---|---|---|---|
| United States | 63 | 53 | 116 |
| Australia | 4 | 7 | 11 |
| Canada | 28 | 31 | 59 |
| Czechia | 1 | 1 | 2 |
| Denmark | 6 | 7 | 13 |
| France | 3 | 5 | 8 |
| Netherlands | 1 | 0 | 1 |
| United Kingdom | 1 | 1 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2016 to primary completion in Mar 2020, 40 months.
Results were first posted in Mar 2022, 1 year 11 months after primary completion.
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Studies of the drug tested here: FT218