3 completed. 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 3 | Completed 3 |
Follow FT218: new trials by email Literature Review of FT218 trials Research Report on FT218
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) FT218, Placebo - Idiopathic Hypersomnia | Phase 3 | Completed | Avadel | 157 | 2024-08-01 | 2026-05-11 |
| An Open Label Study of FT218 in Subjects With Narcolepsy FT218 - Narcolepsy, Cataplexy | Phase 3 | Completed | Avadel | 184 | 2020-06-12 | 2025-10-02 |
| Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy FT218, Placebo - Excessive Daytime Sleepiness, Cataplexy | Phase 3 | Completed | Avadel | 212 | 2016-11-17 | 2022-03-22 |
Cataplexy (2) · Disorders of Excessive Somnolence (2) · Narcolepsy (2) · Idiopathic Hypersomnia (1) · Parasomnias (1) · Sleep Wake Disorders (1)
Avadel (3)
United States (3) · Canada (2) · Australia (1) · Czechia (1) · France (1) · Germany (1)
PMID 34358324, PMID 35380374, PMID 39153911, PMID 39263597, PMID 39321628, PMID 40111738, PMID 40111739, PMID 40851446, PMID 42163487