Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05875974 · ClinicalTrials.gov registry record · Phase 4

A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy

A Phase 4 study, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
207
Enrollment target

NCT05875974: Completed Phase 4 study, sponsored by Jazz Pharmaceuticals.

NCT05875974 is a Phase 4 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 207 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05875974, a Phase 4 study, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
207 participants
Enrollment target

Study Summary

This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.

Primary Outcome

The ESS total score (the sum of 8 item scores, each 0 to 3) can range from 0 to 24. Higher ESS total scores are associated with higher sleep propensity in daily life, also referred to as "daytime sleepiness."

Interventions

  • DRUG JZP258 (XYWAV)

Trial Details

FieldValue
Enrollment Target 207 participants
Start Date 2023-07-27
Est. Completion 2025-03-13
Phase Phase 4
Jazz Pharmaceuticals

128 total trials

What the finished NCT05875974 record still lists

NCT05875974 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which JZP258 (XYWAV) is the first listed.

NCT05875974 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05875974 about?

NCT05875974 is a clinical study titled "A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy". This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.

What is the current status of trial NCT05875974?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 207 participants. The study started on 2023-07-27. Estimated completion is 2025-03-13.

What interventions are being tested in trial NCT05875974?

The interventions under investigation include: JZP258 (XYWAV) (DRUG).

Who is sponsoring clinical trial NCT05875974?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05875974's enrollment target sits among peer trials

207 401st of 2000 higher than 1,600 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04353778 · 207 participants · Phase 1

    Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV

  • NCT05875805 · 207 participants · NA

    A Telehealth Advance Care Planning Intervention

  • NCT06254950 · 207 participants · Phase 2

    A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

  • NCT06904274 · 207 participants · Phase 3

    Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT05875974, the US trial registry maintained by the National Library of Medicine. NCT05875974 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.