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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-50
SponsorFondation Ophtalmologique Adolphe de Rothschild

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Probenecid
  • Placebo

Treatment groups

600 Participants
are divided into 2 treatment groups

Locations

This trial has no locations