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COMPLETED Phase 4

A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy

NCT05869773 · View on ClinicalTrials.gov ↗

Study Summary

The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to XYWAV, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.

Conditions Studied

Interventions

  • DRUG JZP258

Study Locations (20)

California

  • Science 37 — Culver City
  • M3 Wake Research — Encino
  • So Cal Clinical Research — Huntington Beach
  • Long Beach Research Institute — Lakewood
  • Stanford School of Medicine — Redwood City
  • TriValley Sleep Center — San Ramon
  • SDS Clinical Trials, Inc. — Santa Ana

Florida

  • FWD Clinical Research — Boca Raton
  • Meris Clinical Research, LLC — Brandon
  • Ocean Wellness Center — Miami
  • Serenity Research Center LLC — Miami
  • Florida Pediatric Research Institute, LLC — Orlando

Georgia

  • Sleep Practitioners, LLC — Macon

Idaho

  • Saltzer Medical Group — Nampa

Kentucky

  • University of Louisville — Louisville

Maryland

  • University of Maryland Medical Center — Baltimore

Massachusetts

  • Neurocare, Inc — Newton

Michigan

  • Sparrow Health System — Lansing

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2023-06-26
Est. Completion 2025-03-10
Phase Phase 4

Sponsor

Jazz Pharmaceuticals

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05869773

The ClinicalTrials.gov registry entry for NCT05869773 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Narcolepsy appearing as the primary indexed condition, and to 1 intervention — of which JZP258 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05869773 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05869773 about?

NCT05869773 is a clinical study titled "A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy". The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to XYWAV, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new informatio...

What is the current status of trial NCT05869773?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2023-06-26. Estimated completion is 2025-03-10.

What conditions does trial NCT05869773 study?

This clinical trial studies the following conditions: Narcolepsy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05869773?

The interventions under investigation include: JZP258 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05869773?

This trial is sponsored by Jazz Pharmaceuticals, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05869773 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Idaho, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial