JPRN-jRCT2041200095已完成3 期
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome
YAMAMOTO Hideichiro0 个研究点目标入组 375 人开始时间: 2021年1月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 375
研究概览
简要总结
This final report of Study 1503 strongly supports the continued, long-term clinical benefit and safety of ZX008 for the adjunctive treatment of convulsive seizures associated with Dravet syndrome. Robust and sustained, clinically meaningful reductions in seizures were accompanied by expected and manageable TEAEs, no negative effects on executive function, and no cardiovascular abnormalities. Study 1503 thus far supports the persistent profound effectiveness of ZX008 with a favorable benefit: risk profile.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 2age old 至 <= 35age old（—）
- 性别
- All
入选标准
- •Male or non-pregnant, non-lactating female, age 2 to 18 years, inclusive as of the day of the core study Screening Visit.
- •- Satisfactory completion of the core study in the opinion of the investigator and the sponsor.
- •- A documented medical history to support a clinical diagnosis of Dravet syndrome, where convulsive seizures are not completely controlled by current antiepileptic drugs.
- •- Parent/caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability.
- •- Subject's parent/caregiver has been compliant with diary completion during the core study, in the opinion of the investigator (eg, at least 90% compliant).
排除标准
- •- Current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke.
- •- Current or past history of glaucoma.
- •- Moderate or severe hepatic impairment.
- •- Receiving concomitant therapy with: centrally-acting anorectic agents; monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates.
- •- Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days, as maintenance therapy.
- •- A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness at Visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
研究者
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