CTIS2022-502540-12-00进行中（未招募）1 期
A double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety, and tolerability of intravenous ganaxolone added to standard of care in refractory status epilepticus - 1042-SE-3004
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Informed consent signature must be obtained from participant or LAR and once capable (per institutional guidelines), there must be documentation of consent by the participant demonstrating they are willing and aware of the investigational nature of the study and related procedures. Where allowed by law, if the participant lacks the capacity to make informed decisions regarding his/her medical treatment options, the treating clinician may follow their deferred consenting practices. The clinician will make the final decision based on the best interests of the participant., Male or females 18 years of age and older at the time of the first dose of IP., SE meeting the following criteria: a. A diagnosis of SE with or without prominent motor features based on clinical and EEG findings according to investigator's judgement, based on the following: i. For SE with prominent motor features: Clinical and EEG seizure activity indicative of convulsive, myoclonic or focal motor SE; ii. For SE without prominent motor features (nonconvulsive SE): Appropriate clinical features and an EEG indicative of NCSE (see modified Salzburg criteria in Appendix 3) iii. For any type of SE: • Approximetaly 6 minutes of cumulative seizure activity over a 30-minute period within the hour before IP initiation, AND • Seizure activity during the 30 minutes immediately prior to IP initiation, Participants must have received a benzodiazepine and at least 1 of the following IV AEDs for treatment of the current episode of SE administered at an adequate dose and for a sufficient duration, in the judgement of the investigator, to demonstrate efficacy. The benzodiazepine and at least 1 of the IV AEDs must have been administered at a dose that would be expected to be effective for the termination of the current episode of SE, as referred to in Section 12.2 (Appendix 2): • IV Fosphenytoin/phenytoin, • IV Valproic acid, • IV Levetiracetam, • IV Lacosamide, • IV Brivaracetam, or • IV Phenobarbital., BMI < 40 or, if BMI is not able to be calculated at screening, participant is assessed by investigator as not morbidly obese.
排除标准
- •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 a participant to an undue risk of a significant adverse event or would interfere with assessments of safety or efficacy during the study., Anoxic brain injury or an uncorrected, rapidly reversable metabolic condition as the primary cause of SE (eg, hypoglycemia < 50 mg/dL or hyperglycemia > 400 mg/dL)., Participants who have received high-dose IV anesthetics (eg, midazolam, propofol, thiopental, or pentobarbital) during the current episode of SE for more than 18 hours, or who continue to have clinical or electrographic evidence of persistent seizures while receiving high-dose IV anesthetics., Clinical condition or advance directive that would NOT permit admission to the ICU or use of IV anesthesia., Participants known or suspected to be pregnant, Participants with known allergy or sensitivity to progesterone or allopregnanolone medications/supplements, Receiving a concomitant IV product containing Captisol® (marketed products listed in Section 12.4 [Appendix 4])., Known or suspected hepatic insufficiency or hepatic failure leading to impaired synthetic liver function., Known or suspected stage 3B (moderate to severe; eGFR 44-30 mL/min/1.73 m2), stage 4 (severe; eGFR 29-15 mL/min/1.73 m2), or stage 5 (kidney failure; eGFR < 15 mL/min/1.73 m2 or dialysis) kidney disease.
研究者
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