NCT04529954终止1 期
An Open-Label Extension Study to Investigate the Long-Term Safety, and Tolerability of Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization
Cerebral Therapeutics LLC8 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Safety measured as drug or device related SAEs
研究概览
简要总结
This is a non-randomized open-label extension study for subjects having completed protocol DA071976 or CLN100P.01.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the DA07976 or CLN100P.01 Study
- •In the opinion of the investigator, if the subject were to be removed from study and associated therapy, subject would have worsening/increase in disabling seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility.
- •Subject is taking currently approved AED medication(s) (but is not on valproate or divalproex sodium).
- •Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the Investigator, by the subject or caregiver.
- •Subject has hearing, vision, and physical abilities adequate to perform assessments, with or without corrective aids, including keeping a seizure and medication diary during study follow-up.
- •Subject understands study procedures and has voluntarily provided signed, informed consent in accordance with institutional and local regulatory requirements.
- •Needs be literate in English or native language of the country of the study enrollment to complete neuropsychological testing.
- •Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual.
- •Women of childbearing potential must be using a medically accepted method of contraception and have a negative qualitative β-human chorionic growth hormone (β-HCG) pregnancy test result from a urine or blood sample collected per SOE.
排除标准
- •Subject has any significant neurologic disease other than epilepsy.
- •Subject has had status epilepticus refractory to benzodiazepines and phenytoin in the past year
- •Subject is currently taking oral valproic acid or sodium divalproex.
- •Subject has known allergy to valproic acid, divalproex sodium, Epilim, or Depacon.
- •Subject has unstable depression or any major psychiatric disorder including psychosis, major depression, bipolar disorder that in the opinion of the Investigator would put the subject at risk as a participant in the study.
- •Subject has history or evidence of congestive heart failure, clinically significant peripheral edema, or anemia with a hematocrit <30%.
- •Subject has current diagnosis of cancer requiring treatment.
- •Subject in the opinion of the Investigator, is not a suitable candidate for cranial surgery for any reason.
- •Subject has known HIV infection or known or suspected prion disease.
- •Subject has known allergies to drugs or excipients.
- •Subject is breastfeeding, pregnant, or expressed intent on becoming pregnant during the course of the study and Investigator feels pregnancy is a likely outcome during the study
- •In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive CNS disease that in the opinion of the Investigator would put the subject at risk as a participant in the study.
研究组 & 干预措施
Open-Label Safety
Experimental
Participants roll-over from DA071976 or CLN100P.02
干预措施: Valproic Acid delivered to ICV (Drug)
结局指标
主要结局
Safety measured as drug or device related SAEs
时间窗: 2-years
The primary objective is to assess long-term safety and tolerability of ICV delivery of Valproate as measured by drug and device related adverse events.
次要结局
未报告次要终点
研究者
研究点 (8)
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