A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
- Registration Number
- NCT05869773
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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.
Key
- 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 atrial fibrillation detected on screening electrocardiogram (ECG).
- Presence of resistant hypertension.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JZP258 JZP258 Participants will receive 6 to 9 grams per night of JZP258 (XYWAV) for 6 consecutive weeks.
- Primary Outcome Measures
Name Time Method Change from baseline to End of Treatment (EOT) Visit on the 24-hour average Systolic Blood Pressure (SBP) in mmHg Baseline, Up to 6 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline to EOT Visit on the daytime average SBP in mmHg Baseline, Up to 6 weeks Change from baseline to EOT Visit on the seated resting average SBP in mmHg Baseline, Up to 6 weeks Change from baseline to EOT Visit on the nighttime average SBP in mmHg Baseline, Up to 6 weeks
Trial Locations
- Locations (43)
So Cal Clinical Research
🇺🇸Huntington Beach, California, United States
Science 37
🇺🇸Culver City, California, United States
M3 Wake Research
🇺🇸Encino, California, United States
Long Beach Research Institute
🇺🇸Lakewood, California, United States
Stanford School of Medicine
🇺🇸Redwood City, California, United States
TriValley Sleep Center
🇺🇸San Ramon, California, United States
SDS Clinical Trials, Inc.
🇺🇸Santa Ana, California, United States
FWD Clinical Research
🇺🇸Boca Raton, Florida, United States
Meris Clinical Research, LLC
🇺🇸Brandon, Florida, United States
Ocean Wellness Center
🇺🇸Miami, Florida, United States
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