Probenecid for cluster seizures during presurgical epilepsy monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study investigates the antiseizure potential of probenecid in patients with focal epilepsy undergoing presurgical video-EEG monitoring. Participants will receive either probenecid or placebo while seizures and clusters are tracked during ASM withdrawal or planned withdrawal in the monitoring setting. The study leverages the monitoring unit to safely provoke seizures under close observation and to assess seizure burden, Panx1-related mechanisms, and tolerability. Probenecid is considered a repurposed candidate with a favorable safety profile and potential for rapid development if efficacy is shown.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Acute gout attack
* Hyperuricemia secondary to cancer chemotherapy, radiotherapy or myeloproliferative neoplasia
* Primary hyperuricemia due to overproduction of uric acid.
* Participation in an interventional clinical study (drug)
* 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.
* 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.
* Patient who withdrew consent prior to randomization. Patients secondarily excluded will be excluded before randomization and will be replaced.

Where it's running

• Hôpital Fondation A de Rothschild
  Paris, France Recruiting
• Hôpital Fondation A de Rothschild
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Amelie Yavchitz, Dr
• Email: ayavchitz@for.paris
• Phone: +33148036454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.