Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called FT218 compared to a placebo (a dummy treatment with no active ingredient) in people with narcolepsy — a condition that causes extreme daytime sleepiness and sudden episodes of muscle weakness called cataplexy. A total of 107 people were assigned to the FT218 group and 105 to the placebo group. Of those, 69 people in the FT218 group and 79 in the placebo group completed the trial. Three things were measured: how well people stayed awake during a standard test, how much their overall daytime sleepiness improved in their doctor's opinion, and how often cataplexy attacks occurred. The reported data shows the following numbers. On the wakefulness test — where participants tried to stay awake in a quiet room and the time before dozing off was recorded — the FT218 group showed an average improvement of 10.8 minutes from their starting point, compared to 4.7 minutes in the placebo group. For the doctor's overall impression of daytime sleepiness improvement, 72% of people in the FT218 group were rated as "much improved" or "very much improved," compared to 31.6% in the placebo group. Regarding cataplexy attacks, the FT218 group reported an average reduction of 11.5 attacks over the measurement period, while the placebo group reported an average reduction of 4.9 attacks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40851446) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Narcolepsy Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 16 years of age or older (if you are 16 or 17, a parent or legal guardian must also give their permission)
- You are willing and able to sign a consent form agreeing to take part in the study
- You have been officially diagnosed with Type 1 or Type 2 narcolepsy, confirmed through an overnight sleep study and a daytime sleep test showing specific sleep patterns
- You have been experiencing excessive daytime sleepiness for at least the past 3 months, and your score on a standard sleepiness questionnaire (Epworth Sleepiness Scale) is above 10
- If you have Type 1 narcolepsy, you have also been experiencing cataplexy (sudden muscle weakness) for at least the past 3 months
- If you currently take stimulant medication, you have been on the same stable dose for at least 3 weeks before the study starts, and you are willing to keep that dose the same throughout the entire study
- You are willing to stop taking any medications used specifically to treat cataplexy before and during the study
Who may not be able to join:
- You have previously taken sodium oxybate (a common narcolepsy treatment) at a dose higher than 4.5g per night, for longer than 2 weeks, or within the last year
- You are currently taking sodium valproate (a medication used for seizures or mood disorders)
- You are currently taking, or plan to take during the study, any of the following types of medication: anti-seizure drugs, clonidine, antidepressants (including SSRIs, SNRIs, MAOIs, or tricyclics), sleeping pills, anxiety medications, sedating antihistamines, antipsychotics, or any other experimental treatments for narcolepsy or cataplexy
- You have taken part in another clinical trial or used an experimental treatment within the last 3 months
- You take any medication known to affect how you sleep or stay awake (other than stimulants, which are allowed)
- There may be additional reasons you cannot join that are described in the full study protocol (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Maintenance of Wakefulness Test (MWT); Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening; Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.