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

NCT05869773 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2026-04-24

Study results available
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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

Interventions

DRUG

JZP258

0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2025-02-25
Completion
2025-03-10
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05869773 on ClinicalTrials.gov