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Sodium Oxybate

Low-Sodium Oxybate for Narcolepsy

Phase 4

Recruiting

Research Sponsored by Jazz Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 6 weeks

Awards & highlights

Study Summary

This trial looks at how transitioning from a high-sodium oxybate to a low-sodium one affects blood pressure in narcolepsy patients, to provide info for HCPs, patients, and payers.

Who is the study for?

Adults aged 18-70 with narcolepsy, currently treated with high-sodium oxybate and stable doses of any blood pressure or wakefulness medications for at least 6 weeks prior to the study. Participants must not be pregnant, breastfeeding, have unstable medical conditions, significant cardiovascular disease, or psychiatric disorders that could impact their safety or study results.Check my eligibility

What is being tested?

The trial is testing the effect on blood pressure when switching from high-sodium oxybate (XYREM) to a low-sodium version called XYWAV in people with narcolepsy. The goal is to see if reducing sodium intake through medication changes can improve blood pressure.See study design

What are the potential side effects?

While specific side effects are not listed here, participants may experience changes related to lower sodium levels and adjustments in sleep patterns due to the switch from one medication (high-sodium oxybate) to another (low-sodium XYWAV).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline to End of Treatment (EOT) Visit on the 24-hour average Systolic Blood Pressure (SBP) in mmHg

Secondary outcome measures

Change from baseline to EOT Visit on the daytime average SBP in mmHg

Change from baseline to EOT Visit on the nighttime average SBP in mmHg

Change from baseline to EOT Visit on the seated resting average SBP in mmHg

Trial Design

1Treatment groups

Experimental Treatment

Group I: JZP258Experimental Treatment1 Intervention

Participants will receive 6 to 9 grams per night of JZP258 (XYWAV) for 6 consecutive weeks.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor

248 Previous Clinical Trials

34,196 Total Patients Enrolled

15 Trials studying Narcolepsy

3,995 Patients Enrolled for Narcolepsy

Media Library

High-Sodium Oxybate (Sodium Oxybate) Clinical Trial Eligibility Overview. Trial Name: NCT05869773 — Phase 4

Narcolepsy Research Study Groups: JZP258

Narcolepsy Clinical Trial 2023: High-Sodium Oxybate Highlights & Side Effects. Trial Name: NCT05869773 — Phase 4

High-Sodium Oxybate (Sodium Oxybate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05869773 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to partake in this medical experiment?

"This medical trial seeks applicants who are aged between 18 and 70, suffer from narcolepsy, and number around 89."

Answered by AI

Has the United States Food and Drug Administration given its seal of approval to JZP258?

"With Phase 4 authorisation, our team has determined JZP258 to be a 3 on the risk scale."

Answered by AI

Does this medical experiment permit geriatric patients to join?

"The requirements to join this medical trial are that the participant is between 18 and 70 years old. There are 10 research projects for people under 18, while 12 studies target individuals over 65."

Answered by AI

How widely distributed is the trial in city?

"This clinical trial is running at 18 sites, including SDS Clinical Trials Inc. in Santa Ana, Meris Clinical Research in Brandon and the Florida Pediatric Research Institute LLC in Orlando, among other locations."

Answered by AI

Is this research program actively seeking participants?

"Unfortunately, at present this clinical trial is not actively recruiting participants. The study was listed on June 1st 2023 but the last revision occurred on May 12th 2023. But fortunately there are 15 other medical trials seeking candidates currently available to prospective applicants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05869773.

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