Tests probenecid to reduce seizure clusters during epilepsy monitoring

Trial details

Who runs it

Fondation Ophtalmologique Adolphe de Rothschild

Trial code

NCT07318870

Record updated

5 October 2026

Original description

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.Read full original descriptionShow less

Efficacy of Probenecid on Cluster Seizures During Anti Seizure Medication Withdrawal in Presurgical Focal Epilepsy Video-EEG Monitoring

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.

Inclusion: Patients between 6 and 50 years old; Adults, of any weight, who are free from malnutrition or any condition affecting their physiology to any significant degree; or children/adolescents weigheing more than 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, or without dose reduction in the case of epilepsy whose natural history suggests the appearence 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.

Exclusion: Treatment by the following drugs: acetylsalicylic acid, methotrexate (note: the following medications require caution when co-administrated: penicillins, quinolones, cephalosporins including cefadroxil, paracetamol, naproxen, indomethacin, ketoprofen, lorazepam, thiopental, olanzapine, famotidine, clofibrate, valaciclovir, aciclovir, ganciclovir, cidofovir, zidovudine, angiotensin converting enzyme inhibitors and dyprophylline); Participation in an interventional clinical study (drug); Patient who withdrew consent prior to randomization. Patients secondarily excluded will be excluded before randomization and will be replaced; Hyperuricemia secondary to cancer chemotherapy, radiotherapy or myeloproliferative neoplasia; 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; Status epilepticus (a generalized convulsive seizure lasting more than 5 minutes or a focal seizure with impaired awareness lasting more than 10 minutes) occurring before the second seizure that would otherwise define the cluster. In this situation, management should follow the treatment recommendations for status epilepticus; Prolonged impairment of consciousness following the seizure cluster, precluding the safe oral administration of probenecid/placebo tablets; Hypersensitivity to PBN or to any of the excipients (Microcrystalline cellulose, Hypromellose, Sodium carboxymethylamidon, Colloidal anhydrous silica, Magnesium stearate); Known or identified impaired renal function (creatinine clearance < 50 mL/min) in children and adults; Lithiasis diathesis; Acute gout attack; Primary hyperuricemia due to overproduction of uric acid; Pregnant or breast-feeding woman; Patient benefiting from legal protection; Secondary exclusion criteria (before randomization) :.

ClinicalTrials.gov NCT07318870