NCT05757544撤回2 期
A Study to Optimize the Dosing Regimen and Assess Safety and Efficacy of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Absence of electrographic (rapid electroencephalography [EEG]) evidence of status epilepticus or recurrence of convulsions at 1 hour after the first IP bolus administration without the use of any additional medications with anti-seizure properties
研究概览
简要总结
This study is designed to optimize the dosing regimen and evaluate the preliminary safety and efficacy of Intravenous (IV) ganaxolone as adjuvant therapy for participants with ESE receiving initial IV antiepileptic drug (AED) according to currently practiced standard of care (SOC). The study will be composed of 2 phases: an initial, open-label, dose optimization phase followed by IV ganaxolone versus placebo double-blind phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
All participating staff involved in the evaluation and execution of the study will remain blinded to the participant's treatment assignment during the double-blind phase.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females at least 18 years of age at the time of the first IP bolus dose.
- •Has received benzodiazepines before or after arrival to the ED for generalized convulsive seizures lasting more than 5 minutes.
- •Has received the last dose of benzodiazepine more than 5 minutes prior to the first IP bolus initiation.
- •Ongoing or recurrent convulsions, or evidence of electrographic SE on rapid EEG immediately prior to the first IP bolus initiation.
- •The participant has not yet received a second-line IV AED for the treatment of the current episode of SE or the first IP bolus can be initiated within 15 minutes before or 10 minutes after the administration of such IV AED(s).
排除标准
- •The participant is intubated or the decision to proceed with intubation has been made.
- •The cause of SE is acute anoxic brain injury, cardiac arrest, acute trauma, hyper- or hypo-glycemia, or eclampsia.
- •The participant is known or suspected to be pregnant.
- •The participant is incarcerated at the time of SE occurrence.
- •Participants who pre-emptively opted out of the study.
- •A known allergy or sensitivity to progesterone or allopregnanolone medications/ supplements.
- •Receiving a concomitant IV product containing Captisol®.
- •Known estimated glomerular filtration rate (eGFR) <30 milliliters per minute (mL/min) and not receiving dialysis (may initiate first IP bolus prior to acute labs).
- •Individual weighing or suspected to weigh <40 kilograms (kg).
- •Hypotension requiring 2 or more vasopressors.
- •An individual who, in the opinion of the investigator has a life expectancy of less than 24 hours.
- •Use of an investigational product for which less than 30 days or 5 half-lives have elapsed from the final product administration. Participation in a non-interventional clinical study does not exclude eligibility.
- •Known or suspected history or evidence of a medical condition that, in the investigator's judgment, would expose participant to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the study.
研究组 & 干预措施
Dose optimization phase (open label): IV Ganaxolone bolus (variable) followed by infusion (variable)
Experimental
干预措施: IV Ganaxolone (Drug)
Double-blind phase: IV Ganaxolone + SOC
Experimental
干预措施: IV Ganaxolone (Drug)
Double-blind phase: IV Placebo + SOC
Placebo Comparator
干预措施: IV Placebo (Drug)
结局指标
主要结局
Absence of electrographic (rapid electroencephalography [EEG]) evidence of status epilepticus or recurrence of convulsions at 1 hour after the first IP bolus administration without the use of any additional medications with anti-seizure properties
时间窗: At 1 hour
次要结局
- Time to clinical seizure and electrographic SE cessation(Up to Day 7)
- Percentage of participants with no escalation of care (including re-administration of IP) at any point within 24 hours from the initial IP bolus administration(Up to 24 hours)
- Percentage of participants with no escalation to IV anesthesia for treatment of seizures during IP infusion(Up to Day 7)
- Percentage of participants with no escalation to IV anesthesia for treatment of seizures within 24 hours of the initial IP bolus(Up to 24 hours)
- Time to clinical or electrographic seizure recurrence within 24 hours from the initiation of the first IP bolus(Up to 24 hours)
- Percentage of participants with no escalation of care for Status epilepticus (SE) during investigational product (IP) infusion(Up to Day 7)
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