2024-519133-29-00招募中2 期
Efficacy of probenecid on cluster seizures during dosage reduction of Anti Seizure Medication (ASM) in presurgical focal epilepsy video-EEG monitoring
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 10
- 主要终点
- Proportion of patients without seizure between 60 min and 12h after PBN or placebo administration, assessed by the neurologist on video and EEG recording, in patients experiencing SC defined as at least 2 epileptic seizures lasting less than 10 min occurring in 6 hours or less during presurgical hospital videoEEG monitoring for focal epilepsy
研究概览
简要总结
To assess the efficacy of PBN administration on the cessation of seizure recurrence in patients experiencing a cluster seizure upon discontinuation of ASM for pre-surgical hospital video EEG monitoring.
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase II multicenter randomized double-blinded placebo-controlled trial (ratio 1:1)
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients between 6 and 50 years old
- •Children weighing at least 20 kg or adults weighing more than 50 kg
- •With focal seizures epilepsy
- •Requiring video-EEG recording in Epilepsy Monitoring Units (EMU) for the presurgical evaluation of a focal epilepsy, with planned Anti-Seizure Medication (ASM) withdrawal in order to precipitate seizure occurrence, or without dose reduction in the case of epilepsy whose natural history suggests the appearance of seizures without withdrawal.
- •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
- •Affiliated or beneficiary to a social security scheme
排除标准
- •Hypersensitivity to PBN or to any of the excipients (Microcrystalline cellulose, Hypromellose, Sodium carboxymethylamidon, Colloidal anhydrous silica, Magnesium stearate)
- •Pregnant or breast-feeding woman
- •Known or identified impaired renal function (creatinine clearance < 50 ml/min) in children and adults
- •Lithiasis diathesis
- •Treatment with the following drugs: penicillins and other cephalosporins, acetylsalicylic acid, methotrexate, paracetamol, naproxen, indomethacin, ketoprofen, lorazepam, rifampicin, aciclovir, ganciclovir, zidovudine, sulfonamide
- •Acute gout attack
- •Hyperuricemia secondary to cancer chemotherapy, radiotherapy or myeloproliferative neoplasia
- •Primary hyperuricemia due to overproduction of uric acid
- •Participation in an interventional clinical study (drug, medical device, etc.)
- •Patient benefiting from legal protection
结局指标
主要结局
Proportion of patients without seizure between 60 min and 12h after PBN or placebo administration, assessed by the neurologist on video and EEG recording, in patients experiencing SC defined as at least 2 epileptic seizures lasting less than 10 min occurring in 6 hours or less during presurgical hospital videoEEG monitoring for focal epilepsy
Proportion of patients without seizure between 60 min and 12h after PBN or placebo administration, assessed by the neurologist on video and EEG recording, in patients experiencing SC defined as at least 2 epileptic seizures lasting less than 10 min occurring in 6 hours or less during presurgical hospital videoEEG monitoring for focal epilepsy
次要结局
- Introduction of benzodiazepines or increase in weaned antiepileptic medication (if weaned) within 12 hours of treatment administration
- Time spent in seizure in minutes, assessed by the blinded neurologist on video and EEG recording
- Occurrence of tonic-clonic generalized seizure, assessed by the blinded neurologist on video and EEG recording
- Occurrence of a status epilepticus, assessed by the blinded neurologist on video and EEG recording
- Seizure-related injury (bone or tooth fracture, hematoma) assessed by the blinded neurologist
- Interictal activity quantified by the blinded neurologist on video and EEG recording as the evolution of the number of interictal spikes recorded during 15 minutes, 2 hours after treatment administration compared to the same period the day before
- Number of seizures during the rest of video EEG monitoring, assessed by the blinded neurologist on video and EEG recording
- Evolution of heart rate and blood pressure measurements from treatment administration to 2 hours post-administration
- Adverse and serious adverse events
研究者
Dr Amélie Yavchitz
Scientific
Fondation A De Rothschild
研究点 (10)
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