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FT218

DRUG4 trials

Sponsors

Avadel, Flamel Ireland Limited (Ltd) trading under the business name Avadel Ireland

Conditions

CataplexyExcessive Daytime SleepinessExcessive Daytime SomnolenceIdiopathic HypersomniaNarcolepsyNarcolepsy sleep / wake disorderSleep DisorderSleep Disturbance

Phase 3

Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
CompletedNCT02720744
AvadelCataplexy, Excessive Daytime Sleepiness, Narcolepsy
Start: 2016-11-17End: 2020-03-25Updated: 2022-03-22
An Open Label Study of FT218 in Subjects With Narcolepsy
CompletedNCT04451668
AvadelCataplexy, Excessive Daytime Somnolence, Narcolepsy +3
Start: 2020-06-12End: 2024-11-18Updated: 2025-10-02
Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
CompletedNCT06525077
AvadelIdiopathic Hypersomnia
Start: 2024-08-01End: 2026-03-25Updated: 2026-05-11

Unknown Phase

A comparative, open-label, randomized, 2-stage sequential design, 2 periods, crossover study to demonstrate the bioequivalence of 2 FT218 batches (single dose of 4.5 gram) in healthy volunteers
Active, not recruitingNL-OMON44364
Flamel Ireland Limited (Ltd) trading under the business name Avadel IrelandNarcolepsy sleep / wake disorder
Start: 2017-08-07Target: 62Updated: 2024-02-28

Related Papers

Once‐Nightly Sodium Oxybate Meets American Academy of Sleep Medicine Criteria for Treatment of Narcolepsy
Journal of Sleep Research2025-08-251 citations
0832 Clinically Meaningful Improvement in Daytime Sleepiness with ON-SXB in People with Narcolepsy and Severe Sleepiness
SLEEP2025-05-01
0833 Long-Term Safety and Tolerability of Once-Nightly Sodium Oxybate: A Post Hoc Analysis from RESTORE
SLEEP2025-05-01
0834 Hypnagogic/Hypnopompic Hallucination Types Among Participants with Narcolepsy Type 1 from the Phase 3 REST-ON Trial
SLEEP2025-05-01
0836 Consistent Efficacy of Once-Nightly Sodium Oxybate on Disrupted Nighttime Sleep in People with Narcolepsy
SLEEP2025-05-01
0827 Effects of Once-Nightly Sodium Oxybate on Apnea-Hypopnea Index: Post Hoc Analysis from the REST-ON Clinical Trial
SLEEP2025-05-01
0854 Safety and Tolerability of Once-Nightly Sodium Oxybate: A Post Hoc Analysis from the Long-Term RESTORE Study
SLEEP2025-05-01
0859 Correlation Between Maintenance of Wakefulness Test and Epworth Sleepiness Scale Scores in REST-ON
SLEEP2025-05-01
0835 Improvement of Individual Excessive Daytime Sleepiness Symptoms with Once-Nightly Sodium Oxybate for Narcolepsy
SLEEP2025-05-01
0855 Successful Transition from Twice-Nightly Oxybates to Once-Nightly Sodium Oxybate: A Post Hoc Analysis from RESTORE
SLEEP2025-05-01
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.
2025-03-201 citations
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.
2025-03-201 citations
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
Clinical Therapeutics2024-08-163 citations
RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates.
2024-08-153 citations
Improvement in sleep latency with extended-release once-nightly sodium oxybate for the treatment of adults with narcolepsy: Analysis from the phase 3 REST-ON clinical trial.
2024-05-031 citations
0640 Magnitude of Improvement in Excessive Daytime Sleepiness with the Once-at-Bedtime Oxybate for Narcolepsy
SLEEP2024-04-201 citations
0628 Consistent Efficacy of Once-Nightly Sodium Oxybate Across Patient Demographic and Baseline Disease Characteristics
SLEEP2024-04-201 citations
0637 Composite Response with Once-Nightly Sodium Oxybate: Symptom Improvement in Participants with Narcolepsy Type 1
SLEEP2024-04-201 citations
0645 Comparison of Demographics and Baseline Narcolepsy Symptoms Between Participants with NT1 and NT2 from REST-ON
SLEEP2024-04-20
0646 Efficacy Outcomes Among Male and Female Participant Subgroups: A Post Hoc Analysis from REST-ON
SLEEP2024-04-20

22 more papers not shown