Taking people in FrancePhase 2

Tests probenecid to reduce seizure clusters during epilepsy monitoring

Tests probenecid against placebo in people with focal epilepsy during video-EEG monitoring.

Key facts

Who runs it: Fondation Ophtalmologique Adolphe de Rothschild
Where: Paris, FranceSee the site
Trial code: NCT07318870
Registry title: Efficacy of Probenecid on Cluster Seizures During Anti Seizure Medication Withdrawal in Presurgical Focal Epilepsy Video-EEG Monitoring
Status: Recruiting
Phase: Phase 2
People taking part: 600 people, planned
Started: 24 Aug 2026
Expected to end: Sept 2029
Type of study: Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Probenecid
Placebo
Record updated: 5 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 6 to 50 with focal epilepsy who are having video-EEG monitoring before epilepsy surgery. It tests probenecid against placebo for clusters of seizures.

Age: 6 to 50 years old
Sex: Men and women can both join.
Disease stage: Focal epilepsy. Video-EEG monitoring in an epilepsy unit before surgery, with anti-seizure medicine being stopped to bring on seizures, or without dose reduction if seizures are expected anyway. Children and teenagers must weigh more than 20 kg (44 lb).
Earlier treatment: Cannot be taking acetylsalicylic acid or methotrexate. Some other medicines need caution if taken together with the trial drug.

Main reasons for not taking part

Allergy to probenecid or its tablet ingredients
Kidney function below creatinine clearance 50 mL/min
Kidney stone tendency, or acute gout attack
Pregnant or breast-feeding women
Taking part in another drug study

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

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

Who cannot take part

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) :

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 6 and 50 years old?

Where in France

Hôpital Fondation A. de RothschildParis, FranceContact: Gilles HUBERFELD, DrTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

probenecidTreatment being tested
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.
placeboPlacebo, for comparison
Placebo administration in a scheme similar to experimental treatment.