2024-516746-19-00已完成3 期
An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis complex (TSC) and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of Study CRAD001M2304 (EXIST-3)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Frequency and severity of AEs/SAEs
研究概览
简要总结
To evaluate long term safety data
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient is currently enrolled in the Novartis-sponsored EXIST-3 study receiving everolimus and has fulfilled all its requirements
- •Patient is currently benefiting from treatment with everolimus, as determined by the Investigator
- •Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements.
- •Willingness and ability to comply with scheduled visits and treatment plans
- •Written informed consent/adolescent assent obtained prior to enrolling into the roll-over study
排除标准
- •Patient has been permanently discontinued from everolimus study treatment in EXIST-
- •Patient’s indication of TSC with refractory seizures is currently approved and reimbursed for everolimus in the local country
- •Patients who are receiving everolimus in combination with unapproved or experimental treatments for seizure control (AEDs are allowed for the purpose of seizure control).
- •Sexually active males, unless they use a condom during intercourse while taking drug and for 8 weeks after stopping study medication. Males also should not father a child in this period. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
结局指标
主要结局
Frequency and severity of AEs/SAEs
Frequency and severity of AEs/SAEs
次要结局
- Proportion of patients with clinical benefit as assessed by the Investigator at scheduled visits
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (1)
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