EUCTR2016-002977-37-HU进行中（未招募）1 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.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient is currently enrolled in the Novartis-sponsored study CRAD001M2304 receiving everolimus and has fulfilled all its requirements.
- •2. Patient is currently benefiting from treatment with everolimus, as determined by the Investigator.
- •3. Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements.
- •4. Patient is willing and able to comply with scheduled visits and treatment plans.
- •5. Written informed consent/adolescent assent obtained prior to enrolling into the roll-over study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 173
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 43
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient has been permanently discontinued from everolimus study treatment in CRAD001M2304.
- •2. Everolimus is approved for patients with TSC with refractory seizures
- •3. Patients who are receiving everolimus in combination with unapproved or experimental treatments for seizure control Anti-epileptic drug (AEDs) are allowed for the purpose of seizure control).
研究者
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