Study Summary
This trial is testing a new, once-nightly formulation of sodium oxybate (FT218) for the treatment of narcolepsy. The goal is to evaluate the long-term safety and tolerability of FT218 and the ability to switch from the current twice-nightly immediate release sodium oxybate to once-nightly FT218.
- Narcolepsy
- Cataplexy
- Excessive Daytime Sleepiness
- Sleep Wake Disorder
- Sleep Disorders
- Sleep Disorder
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 212 Patients • NCT02720744Awards & Highlights
Trial Design
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Frequently Asked Questions
Are there any available positions for patients who want to enroll in this trial?
"According to the data available on clinicaltrials.gov, this specific trial is no longer recruiting patients. The trial's initial posting date was June 12th 2020 and it was last edited on June 10th 2022. There are, however, 1117 other trials that are actively seeking patients right now."
In how many different geographical areas is this trial being conducted?
"To make participating as easy as possible for enrollees, this trial is being conducted at 23 sites around the country. A few of these locations include Boulder, Springfield and Winter Park."
Does FT218 have the green light from the FDA?
"FT218 has received a score of 3 from our team at Power. This is because it is a Phase 3 trial, which means that while there is data supporting efficacy, multiple rounds of data also support safety."