Efficacy of Probenecid on Cluster Seizures During Anti Seizure Medication Withdrawal in Presurgical Focal Epilepsy Video-EEG Monitoring
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Cessation of seizure recurrence in patients experiencing a cluster seizure
研究概览
简要总结
ProbCluster trial aims at making the proof of concept of antiseizure efficacy of the old antigout PBN in SC, in which Panx1 involvement is relevant on SC pathophysiology and in which efficient therapies are still lacking. The trial will be performed on patients with focal epilepsy in presurgical evaluation undergoing video-EEG monitoring, a setting characterized by a high risk of SC and an efficient video-EEG monitoring of seizures, reducing the risk of erroneous report based on patient home assessment. PBN is a good candidate for a repurposing in epilepsy, due to its brain penetration allowing Panx1 in situ blockade and of its good security profile. The repurposing process allows a faster, safer and cheaper development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 6 and 50 years old
- •weighting > 20 kg
- •With focal seizures epilepsy
- •Requiring video-EEG recording in Epilepsy Monitoring Units (EMU) for the presurgical evaluation of a focal epilepsy, with planned ASM withdrawal in order to precipitate seizure occurrence
- •Able to take an oral therapy
- •Ability to record the patient > 12 hours after the second seizure of the cluster
- •Having received informed information about the study and having signed a consent form to participate in the study. Written consent of both holders of parental authority for minor patients.
排除标准
- •Hypersensitivity to PBN or to any of the excipients (Microcrystalline cellulose, Hypromellose, Sodium carboxymethylamidon, Colloidal anhydrous silica, Magnesium stearate)
- •Impaired renal function (creatinine clearance < 50 mL/min)
- •Lithiasis diathesis
- •Treatment by the following drugs: penicillins cephalosporins, acetylsalicylic acid, methotrexate, acetaminophen, naproxen, indomethacin, ketoprofen, meclofenamate, lorazepam, rifampicin, acyclovir, ganciclovir and zidovudine, sulfonamide, dyprophylline
- •Acute gout attack
- •Hyperuricemia secondary to cancer chemotherapy, radiotherapy or myeloproliferative neoplasia
- •Primary hyperuricemia due to overproduction of uric acid.
- •Pregnant or breast-feeding woman
- •Patient benefiting from legal protection
- •Secondary exclusion criteria (before randomization) :
- •- Patient not randomized: Not experiencing at least 2 seizures lasting less than 10 minutes in 6 hours or less period (defining a SC) during the video-EEG monitoring period OR having no seizure recorded before the cluster.
- •Patients secondarily excluded will be excluded before randomization and will be replaced.
研究组 & 干预措施
probenecid
Oral administration of PBN at a dose of 3g in adults or children weighting > 50 kg; at a dose of 2g in children weighting 35 to 50 kg; and at a dose of 1g in children weighting 20 to 34 kg.
干预措施: Probenecid (Drug)
placebo
Placebo administration in a scheme similar to experimental treatment.
干预措施: Placebo (Other)
结局指标
主要结局
Cessation of seizure recurrence in patients experiencing a cluster seizure
时间窗: Time period from Day 0 to maximum Day 21
Patients without seizure between 60 min and 12h after experimental treatment administration, assessed by the neurologist on video-EEG recording
次要结局
未报告次要终点