Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
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.
Timeline
- Start
- 2016-11-17
- Primary completion
- 2020-03-25
- Completion
- 2020-03-25
Outcome
Met primary endpoint
registry analysis (superiority test); FT218 vs Placebo; p <0.001; Mean Difference (Net) 6.13 (95% CI 3.52 to 8.75) NCT02720744 ↗
registry NUMBER FT218: 72.0 percentage of subjects NUMBER Placebo: 31.6 percentage of subjects analysis (superiority test); FT218 vs Placebo; p <0.001 NCT02720744 ↗
registry analysis (superiority test); FT218 vs Placebo; p <0.001; Mean Difference (Net) -6.65 (95% CI -9.32 to -3.98) NCT02720744 ↗
paper For the three coprimary endpoints and Epworth Sleepiness Scale, all three doses of ON-SXB demonstrated clinically meaningful, statistically significant improvement versus placebo (all p < 0.001). PMID 34358324 ↗
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Oxybate | Unknown | 9 g | Oral |