NCT05055024已完成2 期
A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 22
- 主要终点
- To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)
研究概览
简要总结
This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must complete all Study NLS-1021 study requirements and assessments up to Visit 6;
- •The subject is able, in the opinion of the Investigator, to receive NLS-2 for the 24-week Treatment Phase of this study;
- •Biological females of childbearing potential must agree to use a medically acceptable double-barrier method of contraception for at least 30 days prior to Day 1 and until completion of the study;
- •The subject is able to comply with the open-labelled extension design schedule and other study requirements;
- •The subject provides written informed consent for the open-label extension study.
排除标准
- •The subject meets any Exclusion Criteria for Study NLS-1021 at Visit 6 of that study;
- •The subject receives any investigational drug (other than the COVID-19 vaccine) that is not NLS-2.
研究组 & 干预措施
NLS-2 (mazindol extended release)
Experimental
NLS-2 (mazindol extended release) administered once a day.
干预措施: Mazindol (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)
时间窗: 24 weeks
Summaries of the number and percentage of subjects who experienced Treatment Emergent Adverse Events (TEAEs), TEAEs related to study drug, SAEs, or discontinued study drug or withdrew from the study due to an AE.
次要结局
未报告次要终点
研究者
研究点 (22)
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