JZP-258

DRUG3 trials

Conditions

Idiopathic HypersomniaNarcolepsyNarcolepsy With Cataplexy

Phase 3

A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

Jazz PharmaceuticalsNarcolepsy With Cataplexy

Start: 2017-03-14End: 2019-07-10Updated: 2020-11-12

A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

CompletedNCT03533114

Jazz PharmaceuticalsIdiopathic Hypersomnia

Start: 2018-11-27End: 2020-12-18Updated: 2021-11-24

Phase 4

An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy

CompletedNCT04794491

Jazz PharmaceuticalsNarcolepsy

Start: 2021-03-22End: 2022-11-15Updated: 2024-01-09

2025-12-08

A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia.

2025-07-01

A Patient-centric Clinical Trial Design to Comprehensively Evaluate Low-Sodium Oxybate in People with Idiopathic Hypersomnia or Narcolepsy.

2025-06-09

Effectiveness and optimization of low-sodium oxybate in participants with narcolepsy switching from a high-sodium oxybate: data from the Substitution of Equal Grams of Uninterrupted Xyrem to Xywav study.

2024-09-012 citations

0647 Efficacy of Low-Sodium Oxybate in Narcolepsy Patients with and Without Cardiovascular or Cardiometabolic Disorders

SLEEP2024-04-20

0633 Efficacy and Safety of Low-Sodium Oxybate in Narcolepsy Patients With/Without Psychiatric/Neurologic Comorbidities

SLEEP2024-04-20

0639 Long-term Safety and Timing of Adverse Events with Low-Sodium Oxybate in a Phase 3 Idiopathic Hypersomnia Study

SLEEP2024-04-20

Efficacy of Low-sodium Oxybate by Baseline Sleep Inertia in a Phase 3 Clinical Study in Participants with Idiopathic Hypersomnia (P10-9.003)

Neurology2024-04-09

Long-term efficacy and safety of low-sodium oxybate in an open-label extension period of a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia.

2023-10-018 citations

0592 Efficacy of Lower-Sodium Oxybate by Baseline Sleep Inertia in a Phase 3 Clinical Study in Patients With Idiopathic Hypersomnia

SLEEP2023-05-01

Effects of Low-Sodium Oxybate on 24-Hour Total Sleep Time: Data From a Phase 3 Clinical Study in Adults With Idiopathic Hypersomnia (P5-13.001)

Neurology2023-04-252 citations

Efficacy of Low-Sodium Oxybate in the Treatment of Idiopathic Hypersomnia: Evaluation of Treatment Response Based on the Epworth Sleepiness Scale and Idiopathic Hypersomnia Severity Scale Scores (S6.009)

Neurology2023-04-251 citations

Effectiveness and Optimization of Low-Sodium Oxybate in Participants With Narcolepsy Switching From High-Sodium Oxybate: Interim Data from the Substitution of Equal Grams of Uninterrupted Xyrem to Xywav (SEGUE) Study (P5-13.003)

Neurology2023-04-25

Long-term Safety During a Clinical Trial of Low-Sodium Oxybate in Participants With Narcolepsy With Cataplexy (P5-13.006)

Neurology2023-04-25

Long-Term Safety and Tolerability During a Clinical Trial and Open-Label Extension of Low-Sodium Oxybate in Participants with Narcolepsy with Cataplexy.

2023-03-225 citations

Changes in Cataplexy Frequency in a Clinical Trial of Lower-Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications

CNS Drugs2022-05-3014 citations

0393 Weight Changes During Treatment With Lower-Sodium Oxybate in a Phase 3 Clinical Study in Patients With Narcolepsy

SLEEP2022-05-253 citations

0387 Weight Changes During Treatment With Lower-Sodium Oxybate in a Phase 3 Clinical Study in Patients With Idiopathic Hypersomnia

SLEEP2022-05-252 citations

0386 Long-term Safety During a Clinical Trial of Lower-Sodium Oxybate in Participants With Narcolepsy With Cataplexy

SLEEP2022-05-251 citations

0389 Efficacy of Lower-Sodium Oxybate in the Treatment of Idiopathic Hypersomnia: Evaluation of Response Based on the Epworth Sleepiness Scale Score

SLEEP2022-05-25

7 more papers not shown

JZP-258

Sponsors

Conditions

Phase 3

Phase 4

Related Papers