An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to Xywav
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 86
- 主要终点
- Change from baseline to End of Treatment (EOT) Visit on the 24-hour average Systolic Blood Pressure (SBP) in mmHg
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: JZP258 (Drug)
结局指标
主要结局
Change from baseline to End of Treatment (EOT) Visit on the 24-hour average Systolic Blood Pressure (SBP) in mmHg
时间窗: Baseline, Up to 6 weeks
Change From Baseline to End of Treatment (EOT) Visit on the 24-hour Average Systolic Blood Pressure (SBP) in mmHg
时间窗: Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks
次要结局
- 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)
- 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)
- 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)