A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
Key facts
- Where
- Abington, Austin, Baltimore, Boca Raton, Brandon, Cincinnati, Cleveland, Columbia, Culver City, Dublin, Encino, Greenville, Henderson, Huntersville, Huntington Beach, Lakewood, Lansing, Lincoln, Louisville, Macon, Miami, Nampa, Newton, Orlando, Portland, Redwood City, Rock Hill, San Antonio, San Ramon, and Santa Ana, United StatesSee the 31 sites
- Phase
- Phase 4
Where in United States
- Abington Neurological Associates, LtdAbington, United StatesNo longer taking part
- FutureSearch Trials of NeurologyAustin, United StatesNo longer taking part
- University of Maryland Medical CenterBaltimore, United StatesNo longer taking part
- FWD Clinical ResearchBoca Raton, United StatesNo longer taking part
- Meris Clinical Research, LLCBrandon, United StatesNo longer taking part
- Intrepid Research, LLCCincinnati, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- Bogan Sleep Consultants, LLCColumbia, United StatesNo longer taking part
- Science 37Culver City, United StatesNo longer taking part
- Ohio Sleep Medicine and NeuroscienceDublin, United StatesNo longer taking part
- M3 Wake ResearchEncino, United StatesNo longer taking part
- Velocity Clinical Research - GreenvilleGreenville, United StatesNo longer taking part
- Henderson Clinical Trials,LLCHenderson, United StatesNo longer taking part
- Advanced Respiratory and Sleep Medicine, PLLCHuntersville, United StatesNo longer taking part
- So Cal Clinical ResearchHuntington Beach, United StatesNo longer taking part
- Long Beach Research InstituteLakewood, United StatesNo longer taking part
- Sparrow Health SystemLansing, United StatesNo longer taking part
- Bryan Medical CenterLincoln, United StatesNo longer taking part
- University of LouisvilleLouisville, United StatesNo longer taking part
- Sleep Practitioners, LLCMacon, United StatesNo longer taking part
- Ocean Wellness CenterMiami, United StatesNo longer taking part
- Serenity Research Center, LLCMiami, United StatesNo longer taking part
- Saltzer Medical GroupNampa, United StatesNo longer taking part
- Neurocare, Inc.Newton, United StatesNo longer taking part
- Florida Pediatric Research Institute, LLCOrlando, United StatesNo longer taking part
- OHSU HospitalPortland, United StatesNo longer taking part
- Stanford School of MedicineRedwood City, United StatesNo longer taking part
- Clinical Research of Rock HillRock Hill, United StatesNo longer taking part
- Sleep Therapy Research CenterSan Antonio, United StatesNo longer taking part
- TriValley Sleep CenterSan Ramon, United StatesNo longer taking part
- SDS Clinical Trials, Inc.Santa Ana, United StatesNo longer taking part
Trial details
- Who runs it
- Jazz Pharmaceuticals
- Trial code
- NCT05869773EU 2023-504892-25-00
- Record updated
- 24 April 2026
- Original description
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.Read full original descriptionShow less
An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to Xywav
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.
Inclusion: Participants must be 18 to 70 years of age inclusive, at the time of signing the informed consent; Participants have a documented diagnosis of Type 1 or Type 2 narcolepsy that meets International Classification of Sleep Disorders (ICSD)-3 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria; Participants must have been receiving a total dose of high-sodium oxybate (eg, XYREM) of 6 to 9 g/night (inclusive) with twice-nightly dosing for a minimum of 6 consecutive weeks prior to screening; If currently treated with stimulants and/or alerting agents or other medications known to affect BP, participant must have been taking the same dosing regimen for at least 2 months prior to screening and agree to take the same dose throughout the study; If currently taking stable doses of antihypertensive therapies, participant must maintain these treatments at the same dose throughout the study unless otherwise advised by their medical care; Participant is male or female. A female participant is eligible to participate if she is not pregnant or breastfeeding, if she is a woman of nonchildbearing potential or is a woman of childbearing potential and using a contraceptive method that is highly effective.
Exclusion: History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the participant or interfere with study assessments or the ability of the participant to complete the study based on the judgment of the investigator; Presence of significant cardiovascular disease or cardiovascular condition that in the investigator's opinion may jeopardize participant safety in the study, including screening ECG results; Presence of resistant hypertension; Presence of atrial fibrillation detected on screening electrocardiogram (ECG).