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临床试验/NCT06401707
NCT06401707招募中2 期

PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年5月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
52
试验地点
2
主要终点
Safety and tolerability of perampanel

研究概览

简要总结

Brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. The investigators are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for post-cardiac arrest status epilepticus (PCARSE) prevention after cardiac arrest.

详细描述

More than 500,000 Americans have a cardiac arrest every year and 100,000 survive to hospital admission. Brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. Seizures with or without muscle jerks, i.e. myoclonic seizures, are the most common seizure type after a cardiac arrest. Despite being common, seizures are usually refractory to treatment (post-cardiac arrest refractory status epilepticus) and the vast majority of patients with this diagnosis die. We are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for PCARSE prevention after cardiac arrest. Perampanel is a non-competitive AMPA glutamate receptor antagonist approved for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures, however there are no randomized trials in critically ill cardiac arrest patients at risk for seizures. This medication has been used for the management of refractory status epilepticus, including status epilepticus post-cardiac arrest. We will randomize patients to placebo or perampanel after admission to the intensive care unit. The study's primary outcome will be the incidence of severe adverse events. Secondary efficacy and safety endpoints include incidence of seizures and PCARSE, seizure frequency, time to seizure control, number of anti-seizure medications necessary for seizure control, duration of treatment with anesthetics for seizure control, and time to coma awakening. This study will help determine the safety and feasibility of primary seizure prophylaxis after cardiac arrest.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years old
  • Non-traumatic, out-of-hospital cardiac arrest
  • Comatose on admission - defined as not following commands
  • Return of spontaneous circulation (ROSC) within less than 45 minutes from the time of cardiac arrest (defined as the time of 911 or EMS (emergency medical services) witnessed arrest)
  • Admission to the intensive care unit at Zuckerberg San Francisco General Hospital

排除标准

  • Acute cerebral hemorrhage or infarction
  • Pregnancy
  • Severe kidney function impairment with creatinine clearance inferior to 30 ml/min
  • Severe liver impairment with liver function tests five times above the upper limit of normal
  • Electrographic or electroclinical seizures diagnosis using American Clinical Neurophysiology criteria confirmed by an epileptologist after cardiac arrest

研究组 & 干预措施

Perampanel

Active Comparator

Perampanel oral load of 24mg upon randomization followed by 8mg oral dose daily for four more days (second dose one day after load and total treatment duration is 5 days)

干预措施: Perampanel (Drug)

Placebo

Placebo Comparator

Placebo oral load upon randomization followed by daily placebo oral dose administration for four more days (second dose one day after load and total placebo administration duration is 5 days)

干预措施: Placebo (Drug)

结局指标

主要结局

Safety and tolerability of perampanel

时间窗: 7 days

percentage of participants who are able to complete the 5-day course of perampanel or placebo.

Adverse and Serious Adverse Events

时间窗: 7 days

percentage of participants with treatment-related adverse and serious adverse events in perampanel or placebo arms.

次要结局

  • Neurological function at 180 days(180 days)
  • Time to start of post-cardiac arrest refractory status epilepticus(7 days)
  • Incidence of post-cardiac arrest refractory status epilepticus(7 days)
  • Incidence of post-cardiac arrest seizures(7 days)
  • Treatment intensity of post-cardiac arrest refractory status epilepticus(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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