NCT06792708已完成不适用
A Prospective, Multicenter, Observational Study of LUMRYZ Used in Clinical Practice for the Treatment of Narcolepsy
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Avadel
- 入组人数
- 71
- 试验地点
- 24
- 主要终点
- Epworth Sleepiness Scale
研究概览
简要总结
This is an observational study of LUMRYZ prescribed in clinical practice. Patients are asked if they would be willing to complete questionnaires over a 4-month period after starting LUMRYZ. The questionnaires ask about narcolepsy symptoms, experience with LUMRYZ, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with narcolepsy
- •Oxybate naive or prior treatment with twice-nightly oxybate
- •Access to smart phone, tablet or laptop with reliable internet connection
- •Able to read/understand English
- •Written informed consent and ability to comply with schedule
排除标准
- •Already using LUMRYZ
- •Clinical or mental health condition excluded by LUMRYZ label
- •Any other condition/situation that would adversely impact participation
研究组 & 干预措施
Patients Starting LUMRYZ
The cohort is comprised of patients prescribed LUMRYZ in clinical practice. All dosing decisions are made by the clinician.
干预措施: LUMRYZ (Drug)
结局指标
主要结局
Epworth Sleepiness Scale
时间窗: Baseline to Month 4
Change from the first visit (baseline), prior to start of LUMRYZ, to Month 4; measure of sleepiness with total possible score of 0-24 (higher score equivalent to higher sleepiness)
次要结局
未报告次要终点
研究者
研究点 (24)
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