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.
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
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
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)
Parallel
Probenecid
DrugOral 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.
Placebo
Other interventionPlacebo administration in a scheme similar to experimental treatment
Cessation of seizure recurrence in patients experiencing a cluster seizure
Patients without seizure between 60 min and 12h after experimental treatment administration, assessed by the neurologist on video-EEG recording
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