EUCTR2019-001331-31-FR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 for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome
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 nonpregnant, nonlactating 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 ZX008
- •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: 445
- •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 monoamine oxidase inhibitors, serotonin agonists, serotonin antagonists, and serotonin reuptake inhibitors within 14 days of receiving ZX008
研究者
相似试验
进行中（未招募）
1 期
A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut SyndromeDravet syndrome or Lennox-Gastaut syndromeMedDRA version: 20.1Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: LLTClassification code 10073682Term: Dravet syndromeSystem Organ Class: 100000004850EUCTR2019-001331-31-DEZogenix International Limited650
进行中（未招募）
1 期
A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut SyndromeDravet syndrome or Lennox-Gastaut syndromeMedDRA version: 20.1Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: LLTClassification code 10073682Term: Dravet syndromeSystem Organ Class: 100000004850EUCTR2019-001331-31-SEZogenix International Limited650
进行中（未招募）
1 期
Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeDravet's syndromeMedDRA version: 19.1Level: LLTClassification code 10073682Term: Dravet syndromeSystem Organ Class: 100000004850EUCTR2016-002804-14-FRZogenix International Limited310
进行中（未招募）
1 期
Clinical Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeEUCTR2016-002804-14-ESZogenix International Limited310
已完成
3 期
An extension study to learn about the long-term safety of fenfluramine hydrochloride for seizures in children and adults with rare seizure disorders such as epileptic encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome2024-515680-61-00Zogenix International Limited104