EUCTR2019-001331-31-IT进行中（未招募）1 期
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy forSeizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome -
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 650
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
- •Male or non pregnant, non lactating female
- •Satisfactory completion of a core study
- •Has a rare seizure disorder, such as epileptic encephalopathy and has successfully completed another Zogenix-sponsored clinical trials with
- •Subject's caregiver is willing and able to be compliant with study procedures, visit schedule and study drug accountability
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 205
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Current cardiac valvulopathy or pulmonary hypertension that is clinically significant
- •Moderate or severe hepatic impairment
- •Receiving prohibited medication (please see protocol section 5.6.2), within 14 days of receiving ZX008
研究者
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