2023-504892-25-00已完成3 期
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
- 3 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 14
- 主要终点
- Change from baseline to EOT Visit on the 24-hour average SBP (mm Hg)
研究概览
简要总结
To evaluate the impact of switching from twice-nightly high-sodium oxybate to XYWAV on 24-hour ambulatory SBP for participants with narcolepsy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 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 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. Also refer to exclusion criterion
- •Participant’s average screening SBP must be between 130 and 155 mm Hg (inclusive). Note: BP measurements will be collected using a device provided by the sponsor as described in Section 8.3.2.
- •Participants with resistant hypertension are excluded (refer to exclusion criterion 12).
- •Participant’s average screening Diastolic blood pressure (DBP) must not be greater than 95 mm Hg. Note: BP measurements will be collected using a device provided by the sponsor as described in Section 8.3.2.
- •Participants with resistant hypertension are excluded (refer to exclusion criterion 12).
- •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.
- •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
- •Participant has resistant hypertension, defined as one of the following: a. Controlled BP (ie, SBP < 140 mm Hg and DBP < 90 mm Hg) and treated with 4 or more antihypertensive medications. b. Uncontrolled BP (ie, SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg) despite concurrent use of 3 or more antihypertensive medications of different classes that include a diuretic.
- •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, chronic/persistent atrial fibrillation, ventricular cardiac arrhythmias requiring automatic implantable cardioverter defibrillator or anti-arrhythmic therapy, or any significant 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 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.
结局指标
主要结局
Change from baseline to EOT Visit on the 24-hour average SBP (mm Hg)
Change from baseline to EOT Visit on the 24-hour average SBP (mm Hg)
次要结局
- Change from baseline to EOT Visit on the daytime average SBP (mm Hg)
- Change from baseline to EOT Visit on the seated resting average SBP (mm Hg)
- Change from baseline to EOT Visit on the nighttime average SBP (mm Hg)
研究者
Medical Monitor
Scientific
Jazz Pharmaceuticals PLC
研究点 (14)
Loading locations...
相似试验
招募中
2 期
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and PharmacokineticsNCT07260500Changchun GeneScience Pharmaceutical Co., Ltd.72
尚未招募
不适用
For Patients With Myocardial Infarction and Multiple Vessel: Testing if Ultrasound (UFR) Can Guide All Needed Treatment in One Procedure, Avoiding a Return Hospital Visit for a Second Operation.NCT07264881Beijing Anzhen Hospital200
已完成
3 期
MULTICENTRE, RANDOMISED, DOUBLE-BLIND, VEHICLE AND ACTIVE-CONTROLLED PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML COMPARED TO VEHICLE AND KETOFTIL (KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML) FOR THE TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS.2023-503185-23-00Genetic S.p.A.253
已完成
3 期
Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn's Disease2024-511553-22-00Celgene International II SARL462
已完成
1 期
A Phase 1, Open-label, Randomized, Crossover Study to Assess the Effect of Different Types of Co-administered Oral Liquids on the Relative Oral Bioavailability of a JNJ 77242113 Tablet Formulation in Healthy Participants.2024-515230-32-00Janssen Cilag International16