2024-519133-29-00RecruitingPhase 2
Efficacy of probenecid on cluster seizures during dosage reduction of Anti Seizure Medication (ASM) in presurgical focal epilepsy video-EEG monitoring
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Oct 2026
Brief summary (registry, in English)
To assess the efficacy of PBN administration on the cessation of seizure recurrence in patients experiencing a cluster seizure upon discontinuation of ASM for pre-surgical hospital video EEG monitoring.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 192 (estimated)
- First submitted
- 25 Jun 2025
- Start date
- 28 Jul 2026
- Lead sponsor
- Fondation A De Rothschild
- Diseases
- Epilepsy
- EU CT number
- 2024-519133-29-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 192
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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 surgery and who have a cluster of seizures when their seizure medicine is reduced.
- Age
- 6 to 50 years old. Children and teenagers must weigh more than 20 kg.
- Sex
- Men and women can join.
- Disease stage
- Focal epilepsy that needs video-EEG recording in a hospital epilepsy unit before surgery, with planned stopping of seizure medicine to bring on seizures, or without lowering the dose if seizures usually come anyway.
- Earlier treatment
- Planned reduction or withdrawal of anti-seizure medicine is part of the monitoring. Taking acetylsalicylic acid or methotrexate is not allowed.
Main reasons for not taking part
- Allergy to probenecid or to any of its other ingredients
- Pregnant or breast-feeding women
- Known kidney problems (creatinine clearance below 50 ml/min)
- Kidney stone tendency, acute gout attack, or high uric acid caused by cancer treatment, a bone marrow disease, or too much uric acid production
- Taking acetylsalicylic acid or methotrexate, or taking part in another drug trial
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with the following drugs: acetylsalicylic acid and/or methotrexate (Note: the following medications require caution when co-administered: 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)
Other illness
- Hyperuricemia secondary to cancer chemotherapy, radiotherapy or myeloproliferative neoplasia
Lab values
- 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
Other
- Pregnant or breast-feeding woman
- Lithiasis diathesis
- Acute gout attack
- Primary hyperuricemia due to overproduction of uric acid
- Patient benefiting from legal protection
Who the study is looking for
- 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 and adolescents weighing 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 Anti-Seizure Medication (ASM) withdrawal in order to precipitate seizure occurrence, or without dose reduction in the case of epilepsy whose natural history suggests the appearance 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
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospices Civils de Lyon | Bron | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble Cedex 9 | France | Recruiting |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Recruiting |
| Centre Hospitalier Regional De Marseille | Marseille | France | Recruiting |
| Fondation A. de Rothschild | Paris | France | Recruiting |
| Assistance Publique Hopitaux de Paris | Paris | France | Recruiting |
| Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes | Rennes | France | Recruiting |
| Centre Hospitalier Universitaire Rouen | Rouen Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.