DRKS00033359尚未招募不适用
Prospective German Real World Epidyolex® Beyond Seizure Study - PROGRESS - PROGRESS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 Years 至 one（—）
- 性别
- All
入选标准
- •1.Patients aged 2 years and older, diagnosed with LGS, DS, or TSC.
- •2.The decision to prescribe Epidyolex® as an adjunctive therapy for seizures associated with LGS, DS, or TSC was entirely independent of including the patient in the study.
- •3.Patient, or parent(s)/legal representative(s) must be willing and able to give informed consent/assent for participation in the study.
排除标准
- •1.The patient is currently using or have used cannabis-based products (including recreational, medicinal cannabis, or any other cannabinoid-based products) within the 3 months prior to study entry, unless that has already been observed as part of this study.
- •2.The patient who is already enrolled in any other Jazz-sponsored or funded study must not be enrolled. If a patient is enrolled in another Jazz-sponsored or funded study while they are under observation of the PROGRESS study, their participation in the PROGRESS study must be terminated.
- •3. The patient has the indication LGS or DS and is receiving Epidyolex® not in
- •conjunction with clobazam, and therefore not according to SmPC.
研究者
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