CTIS2023-504892-25-00进行中（未招募）1 期
An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to XYWAV
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 121
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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 ICSD-3 or DSM-5 criteria., Participants must have been receiving a dose of high-sodium oxybate (eg, XYREM) of 6 to 9 g/night (inclusive) 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 Blood Pressure, 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 provider., Participant’s average screening SBP (based on 3 measures at 1-minute intervals) must be between 130 and 145 mm Hg (inclusive)., Participant’s average screening Diastolic blood pressure (DBP) (based on 3 measures at 1-minute intervals) must not be greater than 95 mm Hg., Participant is male or female. • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: - Is a woman of nonchildbearing potential OR - Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year), preferably with low user dependency, as described in Appendix 4 of the Protocol, during the study intervention period and for at least 7 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention. • A WOCBP must have a negative highly sensitive pregnancy test (serum) as required by local regulations during screening (Section 8.3.5 of the Protocol). • Additional requirements for pregnancy testing during and after study intervention are provided in Section 8.3.5 of the Protocol. • The investigator is responsible for review of medical history, contraception history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with an early undetected pregnancy.
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., Occupation requiring nighttime or variable shift work., Participant was previously eligible for this study but either was terminated early or was discontinued., Presence of significant cardiovascular disease including but not limited to: myocardial infarction within the past year, unstable angina pectoris, symptomatic or hospitalized congestive heart failure (ACC/AHA stage C or D), revascularization procedures within the past year, uncontrolled atrial fibrillation, ventricular cardiac arrhythmias requiring automatic implantable cardioverter defibrillator or anti-arrhythmic therapy, any history of cardiovascular disease, or any significant cardiovascular condition that in the investigator’s opinion may jeopardize participant safety in the study., Presence of atrial fibrillation detected on screening ECG., Current or recent (within the past 2 years) diagnosis of a moderate or severe substance use disorder (excluding caffeine) according to DSM-5 criteria. Nicotine use disorder is excluded only if it impacts sleep (ie, a participant who routinely awakens at night to smoke)., History of phenylketonuria or history of hypersensitivity to phenylalanine-derived products., Succinic semi-aldehyde dehydrogenase deficiency by medical history., Received an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to the Screening Period, or plans to use an investigational drug (other than the study drug) during the study., Presence of renal impairment with a calculated creatinine clearance < 45 mL/min., Laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the investigator (clinical chemistry). NOTE: clinical labs may be repeated once during the Screening Period
研究者
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