Efficacy of Probenecid on Cluster Seizures During Anti Seizure Medication Withdrawal in Presurgical Focal Epilepsy Video-EEG Monitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probenecid, Placebo.
- Who it may be relevant to
- Registry conditions: Focal Epilepsy. Basic parameters: 6 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug 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. - Other Placebo
Placebo administration in a scheme similar to experimental treatment
Primary outcome measures
- Cessation of seizure recurrence in patients experiencing a cluster seizure [Time frame: Time period from Day 0 to maximum Day 21]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07318870 · GHD_2024_12