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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JZP258 | Experimental | Eligible participants will be switched, on a gram-for-gram basis, from their prescribed twice-nightly high-sodium oxybate (such as xyrem) to Xywav. Participants who, in the opinion of the investigator, require an adjustment to their Xywav dosing, can increase or decrease their dose by 1.5 grams per night as long as the participant's total nightly dose is between 6 to 9 grams per night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JZP258 | Drug | 0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment (EOT) Visit on the 24-hour Average Systolic Blood Pressure (SBP) in mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to EOT Visit on the Daytime Average SBP in mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks | |
| Change From Baseline to EOT Visit on the Seated Resting Average SBP in mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Science 37 | Culver City | California | 90230 | United States | ||
| M3 Wake Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41090230 | Derived | White WB, Kovacs RJ, Alexander JK, Baranak C, Nichols DA, Fuller DS, Dai J, Whalen M, Ajayi A, Hutchinson B, Dauvilliers Y, Somers VK. Effects of High- Versus Low-Sodium Oxybate on Blood Pressure in Patients With Narcolepsy. Hypertension. 2025 Dec;82(12):2162-2171. doi: 10.1161/HYPERTENSIONAHA.125.25730. Epub 2025 Oct 15. |
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In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
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A total of 155 participants is in the enrolled analysis set. The enrolled analysis set includes all participants who provided informed consent for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | JZP258 | Eligible participants will be switched, on a gram-for-gram basis, from their prescribed twice-nightly high-sodium oxybate (such as xyrem) to Xywav. Participants who, in the opinion of the investigator, require an adjustment to their Xywav dosing, can increase or decrease their dose by 1.5 grams per night as long as the participant's total nightly dose is between 6 to 9 grams per night. Demographics, adverse events and study outcome measures were not analyzed by dose received. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Screening Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2024 | Feb 25, 2026 |
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| Change From Baseline to EOT Visit on the Nighttime Average SBP in mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
| Encino |
| California |
| 91436 |
| United States |
| So Cal Clinical Research | Huntington Beach | California | 92647 | United States |
| Long Beach Research Institute | Lakewood | California | 90805 | United States |
| Stanford School of Medicine | Redwood City | California | 94063 | United States |
| TriValley Sleep Center | San Ramon | California | 94583 | United States |
| SDS Clinical Trials, Inc. | Santa Ana | California | 92705 | United States |
| FWD Clinical Research | Boca Raton | Florida | 33486 | United States |
| Meris Clinical Research, LLC | Brandon | Florida | 33511 | United States |
| Ocean Wellness Center | Miami | Florida | 33169 | United States |
| Serenity Research Center LLC | Miami | Florida | 33176 | United States |
| Florida Pediatric Research Institute, LLC | Orlando | Florida | 32804 | United States |
| Sleep Practitioners, LLC | Macon | Georgia | 31210 | United States |
| Saltzer Medical Group | Nampa | Idaho | 83686 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Neurocare, Inc | Newton | Massachusetts | 02459 | United States |
| Sparrow Health System | Lansing | Michigan | 48911 | United States |
| Bryan Medical Center | Lincoln | Nebraska | 68506 | United States |
| Henderson Clinical Trials LLC | Henderson | Nevada | 89052 | United States |
| Advanced Respiratory and Sleep Medicine, PLLC | Huntersville | North Carolina | 28078 | United States |
| Intrepid Research, LLC | Cincinnati | Ohio | 45245 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Ohio Sleep Medicine and Neuroscience | Dublin | Ohio | 43017 | United States |
| OHSU Hospital | Portland | Oregon | 97239 | United States |
| Abington Neurological Associates, LTD | Abington | Pennsylvania | 19001 | United States |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201 | United States |
| Velocity Clinical Research, Greenville | Greenville | South Carolina | 29615 | United States |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | United States |
| Antwerp University Hospital (UZA) | Edegem | 2650 | Belgium |
| Private Practice RESPISOM Namur | Namur | 5101 | Belgium |
| Hopital Gui de Chauliac | Montpellier | Herault | 34295 | France |
| CHU de Grenoble - Hôpital Albert Michallon | Grenoble | Isere | 38043 | France |
| CHU Nantes - Hôtel Dieu | Nantes | Loire Atlantique | 44093 | France |
| IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB) | Bologna | 40139 | Italy |
| Ospedale San Raffaele (San Raffaele Turro) | Milan | 20127 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Roma | 00133 | Italy |
| Hospital Universitario Araba - Sede Santiago | Vitoria-Gasteiz | Alava | 01004 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General de Castellon | Castellon | 12004 | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | 28040 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period |
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A total of 67 participants are included in the safety analysis set. The safety analysis set includes all participants who took/received at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | JZP258 | Eligible participants will be switched, on a gram-for-gram basis, from their prescribed twice-nightly high-sodium oxybate (such as xyrem) to Xywav. Participants who, in the opinion of the investigator, require an adjustment to their Xywav dosing, can increase or decrease their dose by 1.5 grams per night as long as the participant's total nightly dose is between 6 to 9 grams per night. Demographics, adverse events and study outcome measures were not analyzed by dose received. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to End of Treatment (EOT) Visit on the 24-hour Average Systolic Blood Pressure (SBP) in mmHg | The study protocol defined that if the primary endpoint was met at the prespecified interim analysis, the study endpoints will be evaluated on the interim analysis population. The interim analysis population are the first 43 participants (75%) that have completed the study. Completion of study participation requires completion of the end of trial (EoT) Visit after 6 weeks of study intervention with a 24-hour BP recording at this visit that met the minimal data standards. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
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| Secondary | Change From Baseline to EOT Visit on the Daytime Average SBP in mmHg | The study protocol defined that if the primary endpoint was met at the prespecified interim analysis, the study endpoints will be evaluated on the interim analysis population. The interim analysis population are the first 43 participants (75%) that have completed the study. Completion of study participation requires completion of the end of trial (EoT) Visit after 6 weeks of study intervention with a 24-hour BP recording at this visit that met the minimal data standards. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
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| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to EOT Visit on the Seated Resting Average SBP in mmHg | The study protocol defined that if the primary endpoint was met at the prespecified interim analysis, the study endpoints will be evaluated on the interim analysis population. The interim analysis population are the first 43 participants (75%) that have completed the study. Completion of study participation requires completion of the end of trial (EoT) Visit after 6 weeks of study intervention with a 24-hour BP recording at this visit that met the minimal data standards. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
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| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to EOT Visit on the Nighttime Average SBP in mmHg | The study protocol defined that if the primary endpoint was met at the prespecified interim analysis, the study endpoints will be evaluated on the interim analysis population. The interim analysis population are the first 43 participants (75%) that have completed the study. Completion of study participation requires completion of the end of trial (EoT) Visit after 6 weeks of study intervention with a 24-hour BP recording at this visit that met the minimal data standards. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
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Baseline (Screening) up to 11 weeks
Adverse Events (AEs) and all-cause mortality were assessed during the screening and treatment periods. During the screening period, non-serious AEs reported were recorded as medical history. During the treatment period, both non-serious and serious AEs were collected. AEs were not analyzed by dose level received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JZP258-406 Screening Period | Includes all participants who signed the informed consent form throughout the screening period prior to initiation of study intervention | 0 | 155 | 0 | 155 | 0 | 0 |
| EG001 | JZP258-406 Treatment Period | Includes all participants who received at least 1 dose of study intervention. This period begins after the first dose of study intervention until the last study visit (end of follow up visit) | 0 | 67 | 1 | 67 | 11 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalisation | Surgical and medical procedures | MedDra Version 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDra Version 27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDra Version 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDra Version 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDra Version 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDra Version 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure & Transparency | Jazz Pharmaceuticals Inc. | 215-832-3750 | ClinicalTrialDisclosure@JazzPharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2024 | Feb 25, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Sponsor decision |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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