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.

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Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

6 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probenecid

Drug

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.

Placebo

Other

Placebo administration in a scheme similar to experimental treatment

Primary outcomes

Cessation of seizure recurrence in patients experiencing a cluster seizure

Time frame: Time period from Day 0 to maximum Day 21

Patients without seizure between 60 min and 12h after experimental treatment administration, assessed by the neurologist on video-EEG recording

Study contacts

Contact information is provided by the study sponsor or research team.

Amelie Yavchitz, Dr

CONTACT

[email protected]

+33148036454

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: PROBCLUSTER

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jan 6, 2026
Registry last updated: Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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